Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
- Conditions
- Hepatocellular CarcinomaPancreatic Ductal AdenocarcinomaBiliary Tract CancersEsophageal Squamous Cell CarcinomaTriple Negative Breast CancerHormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast CancerHead and Neck Squamous-Cell CarcinomaPlatinum Resistant High Grade Epithelial Ovarian Cancer
- Interventions
- Registration Number
- NCT06084481
- Lead Sponsor
- AbbVie
- Brief Summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors.
ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called cohorts. Cohorts 1-8 receive ABBV-400 alone (monotherapy) followed by a safety follow-up period. Cohort 9 receives ABBV-400 in combination with a strong CYP3A3 inhibitor (ITZ) followed by a safety follow-up period. Approximately 285 adult participants with hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), esophageal squamous cell carcinoma (ESCC), triple negative breast cancer (TNBC), hormone receptor+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (hormone receptor-positive \[HR+\]/HER2-breast cancer \[BC\]), head and neck squamous-cell-carcinoma (HNSCC), Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer, or advanced solid tumors, will be enrolled in the study in approximately 54 sites worldwide.
In cohorts 1-8, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, HNSCC, and PROC/primary peritoneal/fallopian tube cancer will receive intravenous (IV) ABBV-400 monotherapy and in cohort 9 participants will receive intravenous (IV) ABBV-400 and an oral solution of ITZ, for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 285
- Laboratory values meeting the criteria laid out in the protocol.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), squamous cell carcinoma of the esophagus, (ESCC), triple negative breast cancer (TNBC), hormone receptor+/HER2-breast cancer (HR+/HER2-BC), head and neck squamous-cell-carcinoma (HNSCC), or Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer (by World Health Organization [WHO] criteria). Participant meets the criteria for disease activity laid out in the protocol.
- Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400. Palliative radiation therapy for bone, skin, or subcutaneous metastases with 10 fractions or less is permitted and not subject to a washout period.
- Unresolved clinically significant AEs > Grade 1 from prior anticancer therapy.
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis, including but not limited to those listed in the protocol.
- History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol.
- Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). Participants may continue on antiepileptic therapy if required.
- History of other active malignancy, with the exception of those laid out in the protocol.
- Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis etc.), and prior pneumonectomy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: Hepatocellular Carcinoma (HCC) ABBV-400 Participants with HCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC) ABBV-400 Participants with PDAC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. Cohort 3: Biliary Tract Cancers (BTC) ABBV-400 Participants with BTC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC) ABBV-400 Participants with ESCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. Cohort 5: Triple Negative Breast Cancer (TNBC) ABBV-400 Participants with TNBC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC) ABBV-400 Participants with HR+/HER2-BC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC) ABBV-400 Participants with HNSCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer ABBV-400 Participants with Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. Cohort 9: Drug-Drug Interaction ABBV-400 Participants with advanced or metastatic solid tumors will receive ABBV-400 and a strong CYP3A4 inhibitor (ITZ) for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. Cohort 9: Drug-Drug Interaction Itraconazole (ITZ) Participants with advanced or metastatic solid tumors will receive ABBV-400 and a strong CYP3A4 inhibitor (ITZ) for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to 36 Months ORR defined as percentage of participants with confirmed best overall response of confirmed partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Number of Participants with Adverse Events (AEs) Up to 36 Months An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Maximum Observed Concentration (Cmax) of ABBV-400 Conjugate Up to 36 Months Cmax of ABBV-400 conjugate.
AUC from Time 0 to the End of Dosing Interval (AUCtau) of ABBV-400 Conjugate Up to 36 Months AUCtau of ABBV-400 conjugate.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) for Participants with Confirmed Complete Response (CR)/PR Up to 36 Months DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.
Clinical Benefit Rate Up to 36 Months CBR is defined as the proportion of participants with a best overall response of stable disease at least 5 weeks post first dose, confirmed CR or PR per investigator review according to RECIST, version 1.1
Progression-free Survival (PFS) Up to 36 Months PFS is defined as time from first study treatment to a documented disease progression according to RECIST, version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
Overall Survival (OS) Up to 36 Months OS is defined as time from first study treatment to death due to any cause.
Cmax of ABBV-400 Up to 36 Months Cmax of ABBV-400.
Time to Cmax (Tmax) of ABBV-400 Up to 36 Months Tmax of ABBV-400.
Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration Up to 36 Months AUC for total antibody concentration.
Total Antibody Drug Conjugate (ADC) Concentration Up to 36 Months Total ADC concentration.
Plasma Concentrations of Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload Up to 36 Months Plasma concentrations of unconjugated Top1 inhibitor payload.
Antidrug Antibody (ADA) Up to 36 Months Incidence and concentration of anti-drug antibodies.
Neutralizing Antidrug Antibody (nADA) Up to 36 Months Incidence and concentration of neutralizing anti-drug antibodies.
Tmax of ABBV-400 Conjugate Up to 36 Months Tmax of ABBV-400 conjugate.
Tmax of ABBV-400 Unconjugated Up to 36 Months Tmax of ABBV-400 unconjugated.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-400 Conjugate Up to 36 Months t1/2 of ABBV-400 conjugate.
t1/2 of ABBV-400 Unonjugated Up to 36 Months t1/2 of ABBV-400 unconjugated.
Volume of Distribution at Steady State (Vss) of ABBV-400 Conjugate Up to 36 Months Vss of ABBV-400 conjugate.
Vss of ABBV-400 Unconjugated Up to 36 Months Vss of ABBV-400 unconjugated.
Total Body Clearance at Steady State (CLss) of ABBV-400 Conjugate Up to 36 Months CLss of ABBV-400 conjugate.
CLss of ABBV-400 Unconjugated Up to 36 Months CLss of ABBV-400 unconjugated.
Related Research Topics
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Trial Locations
- Locations (54)
City of Hope National Medical Center /ID# 258645
🇺🇸Duarte, California, United States
Ucsf /Id# 257705
🇺🇸San Francisco, California, United States
University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128
🇺🇸Aurora, Colorado, United States
Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926
🇺🇸Denver, Colorado, United States
Florida Cancer Specialists /ID# 261569
🇺🇸Sarasota, Florida, United States
Northwestern University Feinberg School of Medicine /ID# 257378
🇺🇸Chicago, Illinois, United States
University of Chicago Medical Center /ID# 258197
🇺🇸Chicago, Illinois, United States
START Midwest /ID# 256581
🇺🇸Grand Rapids, Michigan, United States
Washington University-School of Medicine /ID# 257379
🇺🇸St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255132
🇺🇸New York, New York, United States
Scroll for more (44 remaining)City of Hope National Medical Center /ID# 258645🇺🇸Duarte, California, United States