Study of DF1001 in Patients with Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Solid Tumor, Adult
• Interventions: Drug: DF1001; Drug: Nivolumab; Drug: Nab paclitaxel; Drug: Sacituzumab Govitecan-hziy

• Registration Number: NCT04143711
• Lead Sponsor: Dragonfly Therapeutics

Brief Summary

DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either HER2 activated non-small cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 + sacituzumab govitecan-hziy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Study Start: 2019-11-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

General (applies to all cohorts)

1. Signed written informed consent.
2. Male or female patients aged ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months.
4. Baseline Left Ventricular Ejection Fraction (LVEF) ≥ 55% measured by echocardiography (preferred) or multigated acquisition (MUGA) scan.
5. Adequate hematological function.
6. Adequate hepatic function.
7. Adequate renal function.
8. Effective contraception for women of child bearing potential (WOCBP) patients as defined by World Health Organization (WHO) guidelines for 1 "highly effective" method or 2 "effective" methods.

Inclusion Criteria: NSCLC (HER2 Activated) Exploratory Efficacy Cohorts - Monotherapy and Combination with Sacituzumab Govitecan-hziy.

1. Have progression of unresectable locally advanced or metastatic NSCLC after last systemic therapy (as confirmed by investigator) or be intolerant of last systemic therapy.
2. Have HER2 overexpression status (IHC 2+ or 3+), or ERBB2 amplification, or HER2 activating mutation
3. Have recurrent or progressive disease during or after platinum doublet-based chemotherapy.
4. Have received and progressed on or after anti-PD-(L)1 therapy.

Inclusion Criteria: Metastatic Breast Cancer (HR+/HER2-) Exploratory Efficacy Cohort - Monotherapy and Combination with Sacituzumab Govitecan-hziy.

1. Documented evidence of HR+ metastatic breast cancer
2. Documented evidence of HER2- status.
3. Disease progression or recurrence after prior therapy.

Inclusion Criteria: Metastatic Breast Cancer (HER2+) Exploratory Efficacy Cohorts - Combination with Sacituzumab Govitecan-hziy

1. Have histologically confirmed HER2+ breast cancer.
2. Have received prior treatment with trastuzumab, pertuzumab, ado-trastuzumab emtansine (T-DM1), or trastuzumab deruxtecan (T-DXd).
3. Have progression of unresectable locally advanced metastatic breast cancer after last systemic therapy or be intolerant of last systemic therapy.

Inclusion Criteria: Dose Escalation

1. Evidence of objective disease, but participation does not require a measurable lesion.
2. Locally advanced or metastatic solid tumors, for which no standard therapy exists, or standard therapy has failed.
3. HER2 expression by immunohistochemistry and/or erbb2 amplification and/or erbb2 activating mutations.

Inclusion Criteria: "3+3" Nivolumab Combination Cohort

1. Eligible to receive nivolumab per its label for a malignancy of epithelial origin; or
2. Have no standard therapy available, or standard therapy has failed, and must not have received nivolumab prior to joining the study.
3. HER2 expression by immunohistochemistry and/or ebb2 amplification and/or erbb2 activating mutations must be documented on either archival tissue or fresh tumor biopsy.

Inclusion Criteria: "3+3" Nab paclitaxel Combination Cohort

1. Patients must be eligible for treatment with nab-paclitaxel per its label, or have no standard therapy available, or standard therapy has failed.
2. HER2 expression by immunohistochemistry and/or erbb2 amplification and/or erbb2 activating mutations must be documented on either archival tissue or fresh tumor biopsy.

Inclusion Criteria: Safety/PK/PD Expansion Cohorts (Monotherapy and Combination Therapy).

1. Fresh tumor biopsy must be obtained during the screening window.
2. HER2 expression by immunohistochemistry (IHC).
3. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.

Inclusion Criteria: Urothelial Bladder Cancer Expansion Cohort(s).

1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary urothelial, urethra).
3. Patients must have received a platinum containing chemotherapy and an anti PD-1 or anti PD-L1 for the treatment of urothelial bladder cancer.

Inclusion Criteria: Breast Cancer (HER2 Low) Expansion Cohort

1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
2. Histologically documented (metastatic or locally advanced) breast cancer.
3. Absence of erbb2 amplification by ISH and/or HER2 IHC of 0, 1+, or 2+.
4. Patient must have progressed after one line of systemic chemotherapy.

Inclusion Criteria: Breast Cancer (HER2 High) Expansion Cohort

1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
2. Histologically documented (metastatic or locally advanced) breast cancer.
3. Erbb2 amplification by ISH and/or HER2 IHC of 3+, or 2+. If Herceptest score is 2+, ISH results should demonstrate erbb2 amplification.

Inclusion Criteria: Basket erbb2 amplified Expansion Cohort

1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Documented history of erbb2 amplification.
3. Patients must have received at least one line of an approved or established therapy.

Inclusion Criteria: Gastric Cancer (HER2 High) Expansion Cohort

1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Advanced (unresectable/recurrent/metastatic) gastric cancer or cancer of the gastro-esophageal junction.
3. Tumor must have been declared HER2 positive.

Inclusion Criteria: Gastric Cancer (HER2 Low) Expansion Cohort

1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Advanced (unresectable/recurrent/metastatic) gastric cancer or cancer of the gastro-esophageal junction.
3. Tumor must have been declared HER2 low; ISH non-amplified and/or HER2 IHC of 0, 1+ or 2+. If Herceptest score is 0, HER2 must be detected by IHC on at least 1+ of the tumor cells.

Inclusion Criteria: Esophageal Cancer (HER2 High) Expansion Cohort

1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Advanced (unresectable/recurrent/metastatic) esophageal cancer.
3. Tumor must have been declared HER2 positive.

Inclusion Criteria: Esophageal Cancer (HER2 Low) Expansion Cohort

1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Advanced (unresectable/recurrent/metastatic) esophageal cancer.
3. Tumor must have been declared HER2 low; ISH non-amplified and/or HER2 IHC of 0, 1+ or 2+. If Herceptest score is 0, HER2 must be detected by IHC on at least 1+ of the tumor cells.

Inclusion Criteria: Non-small Cell Lung Cancer (HER2 Low) Expansion Cohort

1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease that has been confirmed to have HER2 expression (at least 1+, however, patients must not carry an erbb2 amplification) via archival or fresh biopsy tissue prior to study enrollment.
3. Patients must have recurrent or progressive disease during or after platinum doublet-based chemotherapy.

Inclusion Criteria: Non-small Cell Lung Cancer (HER2 High) Expansion Cohort

1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease that has been confirmed to have amplification of erbb2 via archival or fresh biopsy tissue prior to study enrollment.
3. Patients must have recurrent or progressive disease during or after platinum doublet-based chemotherapy.

Exclusion Criteria

1. Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [with the exception of palliative bone directed radiotherapy], immune therapy, or cytokine therapy except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days or 5 half-lives before the start of study treatment. Note: Patients receiving bisphosphonates are eligible provided treatment was initiated at least 14 days before the first dose of DF1001.
2. Previous malignant disease other than the target malignancy to be investigated in this study within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.
3. Rapidly progressive disease.
4. Active or history of central nervous system (CNS) metastases.
5. Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
6. Significant acute or chronic infections (including historic positive test for human immunodeficiency virus [HIV], or active or latent hepatitis B or active hepatitis C tested during the screening window).
7. Preexisting autoimmune disease (except for patients with vitiligo) needing treatment with systemic immunosuppressive agents for more than 28 days within the last 3 years or clinically relevant immunodeficiencies (eg, dys-gammaglobulinemia or congenital immunodeficiencies), or fever within 7 days of Day 1.
8. Known severe hypersensitivity reactions to mAbs (≥ Grade 3 NCI-CTCAE v5.0), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partly controlled asthma).
9. Persisting toxicity related to prior therapy > Grade 1 NCI-CTCAE v5.0, however alopecia and sensory neuropathy ≤ Grade 2 is acceptable.
10. Pregnancy or lactation in females during the study.
11. Known alcohol or drug abuse.
12. Serious cardiac illness
13. NYHA III of IV heart failure or systolic dysfunction (LVEF < 55%)
14. High-risk uncontrolled arrhythmias ie, tachycardia with a heart rate > 100/min at rest
15. Significant ventricular arrhythmia (ventricular tachycardia) or higher-grade Atrioventricular block (AV-block; second-degree AV-block Type 2 [Mobitz 2] or third-degree AV-block)
16. Angina pectoris requiring anti-anginal medication
17. Clinically significant valvular heart disease
18. Evidence of transmural infarction on ECG
19. Poorly controlled hypertension (defined by: systolic > 180 mm Hg or diastolic > 100 mm Hg)
20. Clinically relevant uncontrolled cardiac risk factors, clinically relevant pulmonary disease or any clinically relevant medical condition in the opinion of the Investigator that may limit participation in this study.
21. Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
22. All other significant diseases (e.g., inflammatory bowel disease), which, in the opinion of the Investigator, might impair the patient's ability to participate
23. Any psychiatric condition that would prohibit the understanding or rendering of informed consent.
24. Legal incapacity or limited legal capacity.
25. Incapable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Combination Therapy with DF1001 and Nivolumab	Nivolumab	Combination dose escalation of DF1001 in combination with nivolumab in patients with select solid tumors.
Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder Cancer	Nivolumab	Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with urothelial bladder cancer using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Monotherapy DF1001 Safety/PK/PD Expansion	DF1001	Expansion cohorts of monotherapy DF1001 in multiple dose levels after evaluation for safety in Monotherapy Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Monotherapy DF1001 Expansion in Urothelial Bladder Cancer	DF1001	Monotherapy expansion cohort enrolling up to 20 patients with urothelial bladder cancer using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low)	DF1001	Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Combination Therapy with DF1001 and Nab-paclitaxel	Nab paclitaxel	Combination dose escalation of DF1001 in combination with nab-paclitaxel in patients with select solid tumors.
Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD Expansion	Nab paclitaxel	Expansion cohort of DF1001 in combination with nab-paclitaxel after evaluation for safety in the Combination Therapy with DF1001 and nab-paclitaxel Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Monotherapy DF1001 Expansion in NSCLC	DF1001	Monotherapy expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documented erbb2 amplification using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Monotherapy DF1001 Exploratory Efficacy Expansion in Metastatic Breast Cancer (HR+/HER2-)	DF1001	Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documentation of HR positive and HER2 negative expression.
DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HR+/HER2-)	DF1001	Combination therapy with DF1001 and sacituzumab govitecan-hziy cohort enrolling up to 40 patients, including safety lead-in, with metastatic breast cancer with documentation of HR positive and HER2 negative expression.
Combination Therapy with DF1001 and Nivolumab Expansion in NSCLC	DF1001	Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Monotherapy DF1001 Expansion in Gastric Cancer	DF1001	Monotherapy expansion cohort enrolling up to 20 patients with gastric cancer with documented high expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Combination Therapy with DF1001 and Nivolumab Expansion in Gastric Cancer	DF1001	Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with gastric cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal Cancer	DF1001	Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with esophageal cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HER2+)	DF1001	Combination therapy with DF1001 and sacituzumab govitecan-hziy cohort enrolling up to 40 patients, including safety lead-in, with metastatic breast cancer with documentation of HER2 positive expression.
Combination Therapy with DF1001 and Nivolumab	DF1001	Combination dose escalation of DF1001 in combination with nivolumab in patients with select solid tumors.
Combo Therapy with DF1001 and Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in NSCLC	DF1001	Combination therapy with DF1001 and sacituzumab govitecan-hziy cohort enrolling up to 20 patients, including safety lead-in, with non-small cell lung cancer with documentation of HER2 activation.
Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High)	DF1001	Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documented high expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Combination Therapy with DF1001 and Nab-paclitaxel	DF1001	Combination dose escalation of DF1001 in combination with nab-paclitaxel in patients with select solid tumors.
Monotherapy DF1001 Dose Escalation	DF1001	Dose escalation cohorts of DF1001 in sequential ascending order.
Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder Cancer	DF1001	Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with urothelial bladder cancer using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Monotherapy DF1001 Expansion in Cancers with Erbb2 Amplification	DF1001	Monotherapy expansion cohort enrolling up to 40 patients with solid tumors showing documented erbb2 amplification using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Combination Therapy with DF1001 and Nivolumab Safety/PK/PD Expansion	DF1001	Expansion cohort of DF1001 in combination with nivolumab after evaluation for safety in the Combination Therapy with DF1001 and nivolumab Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD Expansion	DF1001	Expansion cohort of DF1001 in combination with nab-paclitaxel after evaluation for safety in the Combination Therapy with DF1001 and nab-paclitaxel Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Monotherapy DF1001 Expansion in Esophageal Cancer	DF1001	Monotherapy expansion cohort enrolling up to 20 patients with esophageal cancer with documented high expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Monotherapy DF1001 Exploratory Efficacy Expansion in NSCLC	DF1001	Monotherapy expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documentation of HER2 activation.
Combination Therapy with DF1001 and Nivolumab Safety/PK/PD Expansion	Nivolumab	Expansion cohort of DF1001 in combination with nivolumab after evaluation for safety in the Combination Therapy with DF1001 and nivolumab Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Combination Therapy with DF1001 and Nivolumab Expansion in NSCLC	Nivolumab	Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Combo Therapy with DF1001 and Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in NSCLC	Sacituzumab Govitecan-hziy	Combination therapy with DF1001 and sacituzumab govitecan-hziy cohort enrolling up to 20 patients, including safety lead-in, with non-small cell lung cancer with documentation of HER2 activation.
Combination Therapy with DF1001 and Nivolumab Expansion in Gastric Cancer	Nivolumab	Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with gastric cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal Cancer	Nivolumab	Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with esophageal cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HER2+)	Sacituzumab Govitecan-hziy	Combination therapy with DF1001 and sacituzumab govitecan-hziy cohort enrolling up to 40 patients, including safety lead-in, with metastatic breast cancer with documentation of HER2 positive expression.
DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HR+/HER2-)	Sacituzumab Govitecan-hziy	Combination therapy with DF1001 and sacituzumab govitecan-hziy cohort enrolling up to 40 patients, including safety lead-in, with metastatic breast cancer with documentation of HR positive and HER2 negative expression.

Primary Outcome Measures

Name	Time	Method
Assessment of number of dose limiting toxicities experienced on study as defined per criteria in the study protocol	First 3 weeks of treatment for each subject.	To assess the number of adverse events experienced during the study that meet dose limiting toxicity criteria per the study protocol.
Assess Overall Response Rate	Through 90 days after completion of the study, an average of 1 year.	To assess the confirmed Overall Response Rate (ORR) per RECIST version 1.1 criteria by Investigator Assessment in the Efficacy Phase.
Assess number of adverse events observed during treatment with DF1001 in combination with Nivolumab	Screening visit up to 28 days after last treatment on study.	To assess the safety of DF1001 in Combination therapy with nivolumab by measuring Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Assess number of adverse events observed during treatment with DF1001 in combination with Nab paclitaxel	Screening visit up to 28 days after last treatment on study.	To assess the safety of DF1001 in Combination therapy with Nab paclitaxel by measuring Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Assess number of adverse events observed during treatment with DF1001 in combination with Sacituzumab govitecan-hziy	Screening visit up to 28 days after last treatment on study.	To assess the safety of DF1001 in Combination therapy with Sacituzumab govitecan-hziy by measuring Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0

Secondary Outcome Measures

Name	Time	Method
Assess Best Overall Response by Investigator Assessment.	Through 90 days after completion of the study, an average of 1 year.	To assess confirmed Best Overall Response by Investigator Assessment for patients enrolled in the dose escalation phase and in the efficacy expansion phase.
Evaluation of DF1001 Pharmacokinetics	From start of treatment up through 28 days after last treatment.	Concentration vs time of DF1001 will be measured using blood samples taken a various time points on study
Evaluation of DF1001 Immunogenicity	Every 3 weeks up to 28 days after last treatment.	Evaluate the immunogenicity of DF1001 by measuring the number of patients developing anti-DF1001 antibodies
Assess Overall Survival (OS) Time.	Time from enrollment in the study until death, measured up to 2 years after last treatment on study.	To assess Overall Survival (OS)
Assess Overall Response Rate by Investigator Assessment.	From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months	To assess confirmed and unconfirmed Overall Response Rate (ORR) by Investigator Assessment for patients enrolled in the dose escalation phase.
Assess Duration of Response by Investigator Assessment.	From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months	To assess Duration of Response (DOR) for confirmed responses by Investigator Assessment for patients enrolled in the dose escalation phase and in the efficacy expansion phase.
Assess Progression-free Survival by Investigator Assessment.	From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months	To assess Progression-free Survival (PFS) by Investigator Assessment for patients enrolled in the dose escalation phase and in the efficacy expansion phase.

Trial Locations

Locations (52)

Multicare Health System Tacoma General Hospital; 🇺🇸 Tacoma, Washington, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

Centre Hospitalier de l'Ardenne; 🇧🇪 Arlon, Belgium

Grand Hopital de Charleroi; 🇧🇪 Charleroi, Belgium

Domaine Universitaire du Sart Tilman; CHU de Liege; 🇧🇪 Liège, Belgium

Rigshospitalet; 🇩🇰 Copenhagen, Hovedstaden, Denmark

Herlev og Gentofte Hospital; 🇩🇰 Herlev, Denmark

Groupe Hospitalier Saint Andre; 🇫🇷 Bordeaux, France

Centre Georges-Francois Leclerc; 🇫🇷 Dijon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Leon Berard; 🇫🇷 Lyon, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Institut Regional du Cancer de Montepelier; 🇫🇷 Montpellier, France

Institut Curie; 🇫🇷 Paris, France

Groupe Hospitalier Pitie Salpetriere; 🇫🇷 Paris, France

CHU de Rennes Hopital Pontechaillou; 🇫🇷 Rennes, France

ICO - Site Rene Gauducheau; 🇫🇷 Saint Herblain, France

University of California Irvine Medical Center; 🇺🇸 Irvine, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Sharp Healthcare; 🇺🇸 San Diego, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Kansas Medical Center Research Institute, Inc.; 🇺🇸 Westwood, Kansas, United States

Louisiana State University; 🇺🇸 New Orleans, Louisiana, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Montefiore Einstein Center for Cancer Care; 🇺🇸 Bronx, New York, United States

Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Pennsylvania, Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Institut Claudius Regaud; 🇫🇷 Toulouse Cedex 09, France

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

National Cancer Center; 🇰🇷 Goyang-si, Korea, Republic of

Ajou University Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

CHA Bundang Medical Center, CHA University; 🇰🇷 Gyeonggi-do, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Amsterdam University Medical Center; 🇳🇱 Amsterdam, Netherlands

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Maasticht University Medical Center; 🇳🇱 Maastricht, Netherlands

Radboud University Nijmegen; 🇳🇱 Nijmegen, Netherlands

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands