MedPath

A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor

Phase 1
Recruiting
Conditions
Neoplasms
Liver Neoplasms
Colorectal Neoplasms
Endometrial Neoplasms
Carcinoma, Hepatocellular
Interventions
Registration Number
NCT04008797
Lead Sponsor
Eisai Inc.
Brief Summary

The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s), and to determine the optimal dose of E7386 in combination with lenvatinib in endometrial carcinoma (EC) (for EC Dose Optimization Part only).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
301
Inclusion Criteria

  1. HCC part only:

    Participants with confirmed diagnosis of unresectable HCC with any of the following criteria:

    1. Histologically or cytologically confirmed diagnosis of HCC, excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors
    2. Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria, including cirrhosis of any etiology and/or chronic hepatitis B or C infection

    ST part only (except for HCC):

    Participants with histologically or cytologically confirmed diagnosis of solid tumor for which no alternative standard therapy or no effective therapy exists

  2. Life expectancy of >=12 weeks

  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1

  4. All AEs due to previous anti-cancer therapy have either returned to Grade 0 to 1 except for alopecia or up to Grade 2 peripheral neuropathy (renal/bone marrow/liver function should meet the inclusion criteria)

  5. Adequate washout period before study drug administration:

    1. Chemotherapy and radiotherapy: 3 weeks or 5 times the half-life, whichever is shorter
    2. Any antitumor therapy with antibody: 4 weeks or more
    3. Any investigational drug or device: 4 weeks or more
    4. Blood/platelet transfusion or granulocyte colony-stimulating factor (G-CSF): 2 weeks or more Note: Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not had radiation pneumonitis

  6. Adequate controlled blood pressure (BP), renal function, bone marrow function, liver function, and serum mineral level

  7. At least one measurable lesion based on mRECIST (for HCC Subparts in Dose Escalation Part) or on RECIST 1.1 (for Other ST Subparts in Dose Escalation Part and all subparts in Expansion and Dose Optimization Parts) meeting following criteria

    • At least 1 lesion of >=1.0 centimeter (cm) in the longest diameter for a non-lymph node or >=1.5 cm in the short-axis diameter for a lymph node that is serially measurable according to RECIST 1.1 using computerized tomography (CT)/magnetic resonance imaging (MRI)
    • Lesions that have had external beam radiotherapy or loco-regional therapies such as radiofrequency ablation, or transarterial chemoembolisation (TACE)/ transarterial embolization (TAE) must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion

  8. For HCC participants only: Child-Pugh score A. Note: If Child-Pugh score 7 or more was observed during Screening or Baseline, the participant is ineligible and re-assessment of the Child-Pugh score is not permitted

  9. For HCC participants only: Participants categorized to stage B (not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system

  10. For HCC Subpart in Expansion Part only: prior systemic therapy for locally advanced or metastatic disease is as defined below

    a. Participants who have received only one prior line of immuno oncology (IO) based regimen and have progressed on or after prior treatment with IO based regimen, or IO ineligible participants who have received no prior systemic therapy. Participants who previously received lenvatinib treatment are ineligible

  11. For CRC Subpart in Expansion Part only: participants must have received at least 2 prior regimens (not exceeding 4 prior regimens) or could not tolerate standard treatment and must have received the following prior therapies in the metastatic setting if approved and locally available (progressed on at least 1 prior regimen in the metastatic setting or could not tolerate standard treatment):

    Note: Adjuvant chemotherapy counts as prior systemic treatment if there is documented disease progression within 6 months of treatment completion Note: If a participant is determined to be intolerant to prior standard treatment, the participant must have received at least of 2 cycles of that therapy Note: Participants who have received oral tyrosine kinase inhibitor (example, regorafenib) are ineligible

    1. Fluoropyrimidine, irinotecan and oxaliplatin with or without an anti-Vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) (example, bevacizumab) Note: Capecitabine is acceptable as equivalent to fluoropyrimidine in prior treatment Note: Participants who have previously received fluoropyrimidine, oxaliplatin, and irinotecan as part of the same and only chemotherapy regimen, example, FOLFOXIRI or FOLFIRINOX, may be eligible after discussion with the Sponsor
    2. Chemotherapy with anti- epidermal growth factor receptor (EGFR) mAb (cetuximab or panitumumab) for participants with rat sarcoma virus (RAS) (Kirsten rat sarcoma viral oncogene homolog [KRAS)/ NRAS]) wild type (WT) CRC Note: RAS (KRAS/NRAS) WT participants with right or left CRC lesions who may have not been treated with anti-EGFR mAb based on local guidelines are eligible
    3. BRAF inhibitor (in combination with cetuximab ± binimetinib) for BRAF V600E mutated tumors
    4. Immune checkpoint inhibitor for participants with microsatellite instability-high (MSI-H) CRC

  12. For EC Subpart in Expansion Part only: Participants must have EC that has progressed after prior platinum-based chemotherapy and an anti-programmed cell death (ligand) 1 (PD-[L])1)-directed therapy for EC (participants ineligible for IO therapy who have progressed after prior platinum-based chemotherapy are eligible). Up to 3 prior systemic therapies, of which up to 2 for metastatic or locally advanced disease, are permitted Note: There is no restriction regarding prior hormonal therapies For Dose Optimization Part only: Participants must have EC that has progressed after prior platinum-based chemotherapy and an anti-PD-(L)1-directed therapy for EC. Up to 3 lines of prior therapy, regardless of setting, are allowed. Note: Prior hormonal therapy and radiation are allowed and do not count as prior lines of therapy.

Exclusion Criteria

  1. Any of cardiac conditions as follows:

    • Heart failure New York Heart Association (NYHA) Class II or above
    • Prolongation of QT interval with Fridericias correction (QTcF) to greater than (>) 480 millisecond (msec)
    • Left ventricular ejection fraction (LVEF) less than (<) 50 percent (%)

  2. Major surgery within 21 days or minor surgery (that is, simple excision) within 7 days prior to starting study drug. Participant must have recovered from the surgery related toxicities to less than Grade 2 Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility

  3. Known to be human immunodeficiency virus (HIV) positive Note: the sponsor has evaluated whether to include participant with HIV. Given that this is the first combination study of E7386 with lenvatinib and that the main mechanism of action of E7386 is immunomodulation of the tumor microenvironment along with the fact that several anti-retroviral therapies have drug-drug interaction with cytochrome P450 3A (CYP3A) substrates, the sponsor has decided not to include these participants at the current time. However, further considerations will be made moving forward based on new emerging data Note: HIV testing is required at screening only when mandated by local health authority

  4. Participants with proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein >=1 gram per 24 hour will be ineligible

  5. Active infection requiring systemic treatment (Except for Hepatitis B and/or C [HBV/HCV] infection in HCC participants)

    In case of HBsAg (+) participants in HCC participants:

    • Antiviral therapy for HBV is not ongoing
    • HBV viral load is 2000 international unit per milliliter (IU/mL) or more at the Screening Period although antiviral therapy for HBV is ongoing
    • Has dual active HBV infection (HBsAg (+) and/or detectable HBV deoxyribonucleic acid [DNA]) and HCV infection (anti-HCV Ab (+) and detectable HCV ribonucleic acid [RNA]) at study entry

  6. Diagnosed with meningeal carcinomatosis

  7. Participants with central nervous system metastases are only eligible if they have been previously treated and are radiologically stable, (that is, without evidence of progression for at least 4 weeks prior to first dose of study treatment by repeat imaging), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment

  8. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen

  9. Any of bone disease/conditions as follows:

    • T-score of < minus (-) 3.0 at the left or right total hip, left or right femoral neck or lumbar spine (L1-L4) as determined by dual energy x-ray absorptiometry (DXA) scan. Participants with T-score <-2.5 to -3.0 can only be included if treatment with a bisphosphonate (example, zoledronic acid) or denosumab has been started at least 14 days and no more than 6 months prior to the first dose of study drug
    • Metabolic bone disease, such as hyperparathyroidism, Paget's disease or osteomalacia
    • Symptomatic hypercalcemia requiring bisphosphonate therapy
    • History of any fracture within 6 months prior to starting study drug
    • Bone metastasis requiring orthopedic intervention
    • Bone metastasis not being treated by bisphosphonate or denosumab. Participants may be included if treatment with bisphosphonate or denosumab has been started at least 14 days prior to the first dose of study drug. Participants with previous solitary bone lesions controlled with radiotherapy are eligible
    • History of symptomatic vertebral fragility fracture or any fragility fracture of the hip, pelvis, wrist or other location (defined as any fracture without a history of trauma or because of a fall from standing height or less)
    • Moderate (25% to 40% decrease in the height of any vertebrae) or severe (>40% decrease in the height of any vertebrae) morphometric vertebral fracture at baseline

  10. History of malignancy (except for original disease, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, carcinoma in-situ [example, bladder or cervix]) within the past 24 months prior to the first dose of study drug

  11. For HCC Subpart in Dose Escalation Part only: Participants who experienced discontinuation of lenvatinib, 2 or more dose reductions of lenvatinib required from initial dose level of this study due to its toxicity, or participants who experienced single dose reduction or consecutive >=8 days dose interruption of lenvatinib within 60 days from the first dose, due to its toxicity. HCC Subpart in Expansion Part only: Participants who previously received lenvatinib treatment are ineligible.

    EC Subpart in Expansion Part only: Participants previously treated with lenvatinib who experienced discontinuation of lenvatinib due to toxicity, or dose reduction to less than 10 mg of lenvatinib due to toxicity within 60 days from the first dose.

    EC Dose Optimization Part only: Participants who previously received lenvatinib treatment are ineligible.

  12. Bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic International Normalized Ratio (INR) monitoring for HCC participants only (example, warfarin or similar agents). Treatment with low molecular weight heparin and factor X inhibitors is permitted. Treatment with antiplatelet agents is prohibited for HCC participants in Dose Escalation Part only

  13. Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug

  14. For HCC participants only: History of hepatic encephalopathy within 6 months prior to starting study drug

  15. For EC Subpart in Expansion and Dose Optimization Parts only: carcinosarcoma (malignant mixed Mullerian tumor), endometrial leiomyosarcoma, and endometrial stromal sarcomas

  16. Has preexisting >=Grade 3 gastrointestinal or non-gastrointestinal fistula

  17. Evidence of current Coronavirus disease 2019 (COVID-19) infection or ongoing unrecovered active sequelae of COVID-19 infection

  18. Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners meet the exclusion criteria above (that is, the female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and after study drug discontinuation). No sperm donation is allowed during the study period and after study drug discontinuation

  19. Has a known psychiatric or substance abuse disorder that would interfere with the participant ability to cooperate with the requirements of the study

  20. Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator could affect the participant safety or interfere with the study assessments

  21. Scheduled for major surgery during the study

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Dose Expansion Part: EC Subpart: E7386 + LenvatinibE7386Participants with endometrial cancer (EC) will receive E7386, BID in combination with lenvatinib 14 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Expansion Part: CRC Subpart: E7386 + LenvatinibLenvatinibParticipants with colorectal cancer (CRC) will receive E7386, BID in combination with lenvatinib 20 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Escalation Part: HCC: E7386 QD Subpart + LenvatinibE7386Participants with hepatocellular carcinoma (HCC) will receive E7386, once daily (QD) for 5 or 6 consecutive days followed by a period of time without treatment in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386, QD in combination with lenvatinib 8 milligram (mg) (participants with body weight of less than \[\<\] 60 kilograms \[kg\]) or 12 mg (participants with body weight \>=60 kg), capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Escalation Part: HCC: E7386 QD Subpart + LenvatinibLenvatinibParticipants with hepatocellular carcinoma (HCC) will receive E7386, once daily (QD) for 5 or 6 consecutive days followed by a period of time without treatment in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386, QD in combination with lenvatinib 8 milligram (mg) (participants with body weight of less than \[\<\] 60 kilograms \[kg\]) or 12 mg (participants with body weight \>=60 kg), capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Escalation Part: HCC: E7386 BID Subpart + LenvatinibE7386Participants with HCC will receive E7386, twice daily (BID) for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386, BID in combination with lenvatinib 8 mg (participants with body weight of \< 60 kg) or 12 mg (participants with body weight \>=60 kg) capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Escalation Part: Other ST: E7386 QD Subpart + LenvatinibE7386Participants with solid tumor (ST) (except for HCC) will receive E7386, QD for 5 or 6 consecutive days followed by a period of time without treatment in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386, QD in combination with lenvatinib 20 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Escalation Part: Other ST: E7386 BID Subpart + LenvatinibE7386Participants with ST (except for HCC) will receive E7386, BID for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386, BID in combination with lenvatinib 20 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Expansion Part: HCC Subpart: E7386 + LenvatinibE7386Participants with HCC will receive lenvatinib 8 mg (participants with body weight of \<60 kg) or 12 mg (participants with body weight \>=60 kg), capsule, orally QD in combination with E7386 y, BID in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Expansion Part: CRC Subpart: E7386 + LenvatinibE7386Participants with colorectal cancer (CRC) will receive E7386, BID in combination with lenvatinib 20 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Optimization Part: EC ParticipantsE7386Participants with EC will be randomized to receive 2 different doses of E7386 in combination with lenvatinib capsule or lenvatinib capsule monotherapy in 28-days cycles, or treatment of physician's choice (TPC; doxorubicin in 21-day cycles or paclitaxel in 28-day cycles \[3 weeks on/1 week off\]), until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Escalation Part: HCC: E7386 BID Subpart + LenvatinibLenvatinibParticipants with HCC will receive E7386, twice daily (BID) for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386, BID in combination with lenvatinib 8 mg (participants with body weight of \< 60 kg) or 12 mg (participants with body weight \>=60 kg) capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Escalation Part: Other ST: E7386 QD Subpart + LenvatinibLenvatinibParticipants with solid tumor (ST) (except for HCC) will receive E7386, QD for 5 or 6 consecutive days followed by a period of time without treatment in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386, QD in combination with lenvatinib 20 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Escalation Part: Other ST: E7386 BID Subpart + LenvatinibLenvatinibParticipants with ST (except for HCC) will receive E7386, BID for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386, BID in combination with lenvatinib 20 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Expansion Part: HCC Subpart: Lenvatinib OnlyLenvatinibParticipants with HCC will receive lenvatinib 8 mg (participants with body weight of \<60 kg) or 12 mg (participants with body weight \>=60 kg), capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program
Dose Optimization Part: EC ParticipantsDoxorubicinParticipants with EC will be randomized to receive 2 different doses of E7386 in combination with lenvatinib capsule or lenvatinib capsule monotherapy in 28-days cycles, or treatment of physician's choice (TPC; doxorubicin in 21-day cycles or paclitaxel in 28-day cycles \[3 weeks on/1 week off\]), until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Expansion Part: HCC Subpart: E7386 + LenvatinibLenvatinibParticipants with HCC will receive lenvatinib 8 mg (participants with body weight of \<60 kg) or 12 mg (participants with body weight \>=60 kg), capsule, orally QD in combination with E7386 y, BID in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Expansion Part: EC Subpart: E7386 + LenvatinibLenvatinibParticipants with endometrial cancer (EC) will receive E7386, BID in combination with lenvatinib 14 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Optimization Part: EC ParticipantsLenvatinibParticipants with EC will be randomized to receive 2 different doses of E7386 in combination with lenvatinib capsule or lenvatinib capsule monotherapy in 28-days cycles, or treatment of physician's choice (TPC; doxorubicin in 21-day cycles or paclitaxel in 28-day cycles \[3 weeks on/1 week off\]), until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Dose Optimization Part: EC ParticipantsPaclitaxelParticipants with EC will be randomized to receive 2 different doses of E7386 in combination with lenvatinib capsule or lenvatinib capsule monotherapy in 28-days cycles, or treatment of physician's choice (TPC; doxorubicin in 21-day cycles or paclitaxel in 28-day cycles \[3 weeks on/1 week off\]), until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Primary Outcome Measures
NameTimeMethod
Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs)Cycle 0 (Cycle 0 length=6 or 7 days) up to Cycle 1 (Cycle 1 length=28 days)

DLTs will be defined as any of the events that are considered by the investigator to be at least possibly related to therapy with the study medication. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0).

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)Up to 30 days after the last dose of study drug or before initiating post anti-cancer treatment (up to approximately 60 months)
Dose Optimization Part: Objective Response Rate (ORR) per RECIST 1.1 by Investigator Assessment at Week 24At Week 24

The ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR). The ORR will be assessed by investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for dose optimization part.

Secondary Outcome Measures
NameTimeMethod
Dose Escalation Part: Cmax: Maximum Observed Plasma Concentration for E7386Day 1 to Day 8
Dose Escalation Part: Cmax: Maximum Observed Plasma Concentration for LenvatinibDay 8
Dose Escalation Part: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7386Day 1 to Day 8
Dose Escalation Part: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for LenvatinibDay 8
Dose Escalation Part: AUC: Area Under the Plasma Concentration Versus Time Curve for E7386Day 1 to Day 8
Dose Escalation Part: AUC: Area Under the Plasma Concentration Versus Time Curve for LenvatinibDay 8
Dose Escalation Part: CL/F: Apparent Total Body Clearance for E7386Day 1 to Day 8
Dose Escalation Part: CL/F: Apparent Total Body Clearance for LenvatinibDay 8
Dose Escalation Part: Vz/F: Apparent Volume of Distribution for E7386Day 1 to Day 8
Dose Escalation Part: Vz/F: Apparent Volume of Distribution for LenvatinibDay 8
Percentage of Participants with Best Overall Response (BOR)From first dose of study drug until progression of disease (PD), development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 60 months)

BOR is defined as confirmed CR, confirmed PR, stable disease (SD), PD, and not evaluable (NE). The BOR will be assessed by investigator based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for HCC subparts in dose escalation part and based on RECIST version 1.1 for ST subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.

Objective Response Rate (ORR)From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 60 months)

The ORR is defined as the percentage of participants with a BOR of CR or PR. The ORR will be assessed by investigator based on mRECIST for HCC subparts in dose escalation part and based on RECIST version 1.1 for ST-subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.

Disease Control Rate (DCR)From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 60 months)

DCR is defined as the percentage of participants with a BOR of CR, PR, or SD. The DCR will be assessed by investigator based on mRECIST for HCC subparts in dose escalation part and based on RECIST version 1.1 for ST-subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.

Clinical Benefit Rate (CBR)From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 60 months)

The CBR is defined as the percentage of participants with a BOR of CR, PR, or durable SD. The CBR will be assessed by investigator based on mRECIST for HCC subparts in dose escalation part and based on RECIST version 1.1 for ST-subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.

Progression-free Survival (PFS)From first dose of study drug until PD, or death from any cause, whichever occurs first (up to approximately 60 months)

PFS is defined as the time from the date of the first dose to the date of the first documentation of confirmed PD or death, whichever occurs first.

Overall Survival (OS)From first dose of study drug until death from any cause (up to approximately 60 months)

OS is defined as the time from the first dose of study drug to death due to any cause. OS will be calculated for all subparts in dose expansion part, dose optimization part, and HCC subparts in dose escalation part only.

Duration of Response (DOR)From first dose of study drug until PD, or death from any cause, whichever occurs first (up to approximately 60 months)

DOR is defined as the time from the first documentation of PR or CR to the first documentation of disease progression or death due to any cause (whichever occurs first).

Trial Locations

Locations (105)

ICANs

🇫🇷

Strasbourg, France

Gustave Roussy Institute (IGR)

🇫🇷

Villejuif, France

Clinica Oncologica AOU (Azienda Ospedaliero Universitaria) delle Marche

🇮🇹

Ancona, Italy

CHU Cavale Blanche

🇫🇷

Brest, France

Centre François Baclesse

🇫🇷

Caen, France

UAMS

🇺🇸

Little Rock, Arkansas, United States

University of California San Diego (UCSD) - Moores Cancer Center(All)

🇺🇸

La Jolla, California, United States

Cedars-Sinai Medical Center

🇺🇸

Los Angeles, California, United States

Pasadena Liver Center

🇺🇸

Pasadena, California, United States

California Pacific Medical Center

🇺🇸

San Francisco, California, United States

UCLA University of California - Los Angeles

🇺🇸

Santa Monica, California, United States

John Muir Clinical Research

🇺🇸

Walnut Creek, California, United States

University of Colorado Cancer Center - Anschutz Medical Campus

🇺🇸

Aurora, Colorado, United States

Uni. Of Miami- Sylvester Cancer Centre

🇺🇸

Miami, Florida, United States

Florida Cancer Specialists - South

🇺🇸

Sarasota, Florida, United States

Florida Cancer Specialists - East

🇺🇸

West Palm Beach, Florida, United States

Women's Cancer Care - Covington, LA

🇺🇸

Covington, Louisiana, United States

University Of Mississippi Medical Center

🇺🇸

Jackson, Mississippi, United States

Kansas City Research Institute

🇺🇸

Kansas City, Missouri, United States

Montefiore Medical Center (MMC) - Jack D. Weiler Hospital

🇺🇸

Bronx, New York, United States

Perlmutter Cancer Center- NYU Langone Health

🇺🇸

New York, New York, United States

Memorial Sloan Kettering Cancer Center

🇺🇸

New York, New York, United States

MetroHealth Medical Center

🇺🇸

Cleveland, Ohio, United States

ProMedica Flower Hospital

🇺🇸

Sylvania, Ohio, United States

University of Oklahoma Health Science Center

🇺🇸

Oklahoma City, Oklahoma, United States

UPMC

🇺🇸

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

Sanford Cancer Centre

🇺🇸

Sioux Falls, South Dakota, United States

Tennessee Oncology

🇺🇸

Nashville, Tennessee, United States

Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville

🇺🇸

Nashville, Tennessee, United States

Mary Crowley Cancer Research

🇺🇸

Dallas, Texas, United States

University of Texas Southwestern Medical

🇺🇸

Dallas, Texas, United States

MD Anderson Cancer Center

🇺🇸

Houston, Texas, United States

Fred Hutchinson/University of Washington Cancer Consortium

🇺🇸

Seattle, Washington, United States

Sunnybrook Hospital

🇨🇦

Toronto, Ontario, Canada

CHUM, Unit for Innovative Therapies

🇨🇦

Montreal, Quebec, Canada

McGill University Health Centre

🇨🇦

Montreal, Quebec, Canada

Beijing Cancer Hospital

🇨🇳

Beijing, China

Peking Union Medical College Hospital

🇨🇳

Beijing, China

Bethune Hospital of Jilin University

🇨🇳

Changchun, China

Fujian Provincial Cancer Hospital

🇨🇳

Fuzhou, China

Sun Yan-sen University Cancer Center

🇨🇳

Guangzhou, China

Sun Yat-Sen Memrial Hospital, Sun Yat-Sen University

🇨🇳

Guangzhou, China

Cancer Hospital of Shandong First Medical University

🇨🇳

Jinan, China

Yunnan Cancer Hospital

🇨🇳

Kunming, China

Fudan University Cancer Center

🇨🇳

Shanghai, China

The Tenth People's Hospital; Shanghai Tongji University

🇨🇳

Shanghai, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

🇨🇳

Shenzhen, China

Tianjin Cancer Hospital

🇨🇳

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

🇨🇳

Wenzhou, China

Rigshospatalet

🇩🇰

Copenhagen, Denmark

Odense University Hospital

🇩🇰

Odense, Denmark

CHU Amiens-Picardie (Hopital Sud)

🇫🇷

Amiens, France

CHU Bordeaux

🇫🇷

Bordeaux, France

Centre Jean Perrin

🇫🇷

Clermont-Ferrand, France

Hôpital Beaujon

🇫🇷

Clichy, France

Centre Georges-François Leclerc

🇫🇷

Dijon, France

Grenoble University Hospital (Centre Hospitalier Universitaire Grenoble Alpes)

🇫🇷

La Tronche, France

CHU de LILLE - Hôpital HURIEZ

🇫🇷

Lille, France

Hepatology, Hopital de la Croix-Rousse - 103 grande rue de la Croix-Rousse

🇫🇷

Lyon, France

Centre Léon Bérard

🇫🇷

Lyon, France

Institut Paoli-Calmettes

🇫🇷

Marseille, France

Centre Antoine Lacassagne

🇫🇷

Nice, France

Institut Curie - Centre de Recherche

🇫🇷

Paris, France

APHP Hospital Saint-Antoine

🇫🇷

Paris, France

AP-HP Université de Paris, Port Royal

🇫🇷

Paris, France

Hopital Europeen Georges-Pompidou (HEGP)

🇫🇷

Paris, France

Hopital de la Croix Saint-Simon

🇫🇷

Paris, France

Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux)(Hopitaux de Bordeaux) - Groupe hospitalier Sud - Hopital Haut-Levequ

🇫🇷

Pessac, France

Centre Hospitalier Universitaire (CHU) de Poitiers

🇫🇷

Poitiers, France

Insitute de Cancérologie de l'Ouest - Centre René Gauducheau

🇫🇷

Saint-Herblain, France

Istituto Clinico Humanitas, Rozzano

🇮🇹

Milan, Italy

Fondazione Policlinico Gemelli IRCCS

🇮🇹

Rome, Italy

Eisai Trial Site #5

🇰🇷

Jongno-gu, Seoul, Korea, Republic of

Eisai Trial Site #11

🇯🇵

Toyoake, Aichi, Japan

Eisai Trial Site #2

🇰🇷

Seodaemun, Seoul, Korea, Republic of

Eisai Trial Site #8

🇯🇵

Matsuyama, Ehime, Japan

Eisai Trial Site #7

🇯🇵

Kurume, Fukuoka, Japan

Eisai site #13

🇯🇵

Akashi, Hyogo, Japan

Eisai Trial Site #10

🇯🇵

Kawasaki, Kanagawa, Japan

Eisai Trial Site #12

🇯🇵

Kamigyo-ku, Kyoto, Japan

Eisai Trial Site #3

🇰🇷

Seoul, Korea, Republic of

Eisai Trial Site #9

🇯🇵

Hidaka, Saitama, Japan

Eisai Trial Site #1

🇰🇷

Seongnamsi Bundang, Gyeonggi-Do, Korea, Republic of

Eisai Trial Site #6

🇯🇵

Koto-ku, Tokyo, Japan

Eisai Site 15

🇯🇵

Minato-ku, Tokyo, Japan

Eisai Trial Site #4

🇰🇷

Songpa-gu, Seoul, Korea, Republic of

Eisai site #14

🇯🇵

Niigata, Japan

National Cancer Center

🇰🇷

Goyang-si Gyeonggi-do, Ilsandong-gu, Korea, Republic of

Korea University Guro Hospital

🇰🇷

Guro-gu, Seoul, Korea, Republic of

Seoul National University Hospital

🇰🇷

Jongno-gu, Seoul, Korea, Republic of

Seoul St. Mary's Hospital

🇰🇷

Seocho-Gu, Seoul, Korea, Republic of

Asan Medical Centre

🇰🇷

Songpa-Gu, Seoul, Korea, Republic of

H. Clinico San Carlos

🇪🇸

San Carlos, Madrid, Spain

Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO)

🇪🇸

Barcelona, Spain

University Hospital A Coruña

🇪🇸

Coruna, Spain

Hospital Universitario de Jaén

🇪🇸

Jaen, Spain

Clínica Universidad de Navarra

🇪🇸

Madrid, Spain

Hospital Universitario 12 de Octubre

🇪🇸

Madrid, Spain

Chang Gung Medical Foundation - Kaohsiung Branch

🇨🇳

Kao-Hsiung, Taiwan

Taichung Veterans General Hospital

🇨🇳

Taichung, Taiwan

National Cheng Kung University Hospital

🇨🇳

Tainan, Taiwan

National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

Taipei Veterans General Hospital

🇨🇳

Taipei, Taiwan

Chang Gung Medical Foundation - Linkou Branch

🇨🇳

Taoyuan, Taiwan

Related Trials

Study of E7386 in Participants With Selected Advanced Neoplasms

Active, Not RecruitingPhase 1
Eisai Inc.
Posted 8/29/2017
Updated 6/11/2024

Related News

Eisai to Present Long-Term LEAP-002 Data and Novel Pipeline Advances at ASCO 2025

• Eisai will showcase long-term follow-up data from the Phase 3 LEAP-002 study evaluating lenvatinib plus pembrolizumab versus lenvatinib monotherapy in first-line unresectable hepatocellular carcinoma treatment.

• The company will present research on E7386, a CBP/β-catenin interaction inhibitor, in combination with lenvatinib for patients with advanced or recurrent endometrial carcinoma, addressing significant unmet medical needs.

• Final analysis data from the Phase 3 LEAP-015 study examining lenvatinib plus pembrolizumab and chemotherapy in advanced gastroesophageal adenocarcinoma will be featured in an oral presentation.

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