Brief Summary: This study will test the safety, including side effects, and determine the characteristics of a drug called GEN1160 (PRO1160) in participants with solid tumors and blood cancers. Participants will have cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable) or relapsed or refractory to prior treatments. This Phase 1/2 study will have three parts. The dose escalation part of the study will find out how much and how frequently GEN1160 should be given to participants. The expansion Part A and expansion Part B will use the dose and schedule found in the dose escalation part to find out how safe GEN1160 is and if it works to treat the diseases under study. The diseases under study will be Renal Cell Carcinoma (RCC), Nasopharyngeal Carcinoma (NPC) and Non-Hodgkin Lymphoma (NHL) in Escalation and diffuse large B-cell lymphoma (DLBCL) in expansion Part A and Part B.
This is a Phase 1/2 study of GEN1160, a CD70 targeted antibody-drug conjugate, to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of GEN1160 in participants with selected locally advanced /or metastatic solid and hematologic malignancies, including RCC, NPC and NHL. This study consists of 3 parts, Dose Escalation, Expansion Part A and Expansion Part B. Dose escalation may evaluate up to 5 dose levels of GEN1160 on Day 1 of a 21 day cycle by intravenous (IV) infusion. Expansion will be initiated at a dose level based on a comprehensive analysis of safety, tolerability, clinical PK, pharmacodynamics (PD) and activity data from the dose escalation. Expansion will be conducted in 1 cohort of up to 10 participants (expansion Part A) and 2 further cohorts (expansion Part B), each with up to 25 participants per cohort. Participants will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, initiation of non-GEN1160 anticancer therapy, participant noncompliance, pregnancy, or death.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
IV infusion of GEN1160
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, United States
The City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
Montefiore Medical Center - Montefiore Hospital
The Bronx, New York, United States
Levine Cancer Center
Charlotte, North Carolina, United States
Cleveland Clinic - Euclid Hospital
Cleveland, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
...and 7 more locations
Dose Escalation: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 1 year
Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: 28 days
Expansion Parts A and B: Objective Response Rate (ORR)
Time frame: Up to approximately 1 year
Dose Escalation: ORR
Time frame: Up to approximately 1 year
Dose Escalation: Disease Control Rate (DCR)
Time frame: Up to approximately 1 year
Dose Escalation and Expansion Parts A and B: Progression-free Survival (PFS)
Time frame: Up to approximately 18 months
Dose Escalation and Expansion Parts A and B: Duration of Objective Response (DOR)
Time frame: Up to approximately 1 year
Dose Escalation and Expansion Parts A and B: Peak Plasma Concentration (Cmax) of GEN1160-related Analytes
Time frame: Up to approximately 1 year
Dose Escalation and Expansion Parts A and B: Time to Maximum Concentration (Tmax) of GEN1160-related Analytes
Time frame: Up to approximately 1 year
Dose Escalation and Expansion Parts A and B: Area Under the Curve up to the Last Quantifiable Time-point (AUC0-last) of GEN1160-related Analytes
Time frame: Up to approximately 1 year
Dose Escalation and Expansion Parts A and B: Number of Participants with Antidrug Antibodies (ADA)
Time frame: Up to approximately 1 year
Expansion Parts A and B: Complete Response (CR) Rate
Time frame: Up to approximately 1 year
Expansion Parts A and B: Overall Survival (OS)
Time frame: Up to approximately 18 months
Expansion Parts A and B: Number of Participants with TEAEs
Time frame: Up to approximately 1 year
Expansion Parts A and B: Number of Participants with Anti-GEN1160 Antibodies
Time frame: Up to approximately 1 year
Expansion Parts A and B: Time-to response (TTR)
Time frame: Up to approximately 1 year
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