NCT04121676

Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer

A Phase 1 Study of AGEN2373, an Anti-CD137 Monoclonal Antibody, as Monotherapy and in Combination With AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody, in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Agenus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, PK, and PD profiles of AGEN2373 as a monotherapy and in combination with botensilimab (also known as AGEN1181), and to assess the maximum tolerated dose (MTD) in subjects with advanced solid tumors.

Detailed description

This Phase 1 study will enroll up to approximately 200 evaluable adult patients with a histologically confirmed diagnosis of advanced cancer for which no standard therapy is available or standard therapy has failed, regardless of diagnosis and prior therapies. This also includes patients with PD-1/PD-L1 R/R melanoma. Patients may be enrolled into one of 5 treatment arms: 2-Week AGEN2373 monotherapy 3-Week AGEN2373 monotherapy 4-Week AGEN2373 monotherapy Combination of AGEN2373 and botensilimab in patients with programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) relapsed/refractory (R/R) melanoma. Group 1 (Monotherapy Lead-in Combination): AGEN2373 will be administered every 3 weeks (Q3W). Starting on Cycle 4, AGEN1181 will be administered on Day 1 of every other 3-week cycle (Cycles 4, 6, 8, etc.) in combination with AGEN2373. Group 2 (Combination): AGEN2373 will be administered Q3W in combination with botensilimab administered every other cycle. The trial will consist of a 3+3 dose escalation that will evaluate different combination dose levels of AGEN2373 monotherapy and in combination with botensilimab. Each patient will stay on the dose level and schedule assigned at trial entry. Treatment with AGEN2373 monotherapy will be up to 2 years (i.e., maximum of 34 cycles). For combination therapy, AGEN1181 will be continued up to 1 year (i.e., maximum of 8 doses) and for AGEN2373 up to 2 years (i.e., maximum of 34 cycles), or until unacceptable toxicity, disease progression, consent is withdrawn, or any criterion for stopping the study drug or withdrawal of trial occurs. Patients who do not complete the DLT observation period (28 days for the 2-Week and 4-Week AGEN2373 Monotherapy arms and 21 days for the 3-Week AGEN2373 Monotherapy and Combination arms) after the first dose for reasons other than DLT will be replaced.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	AGEN2373	An Anti-CD137 Monoclonal Antibody
DRUG	Botensilimab	Anti-CTLA-4 Monoclonal Antibody

Timeline

• Start date: 2019-09-26
• Primary completion: 2024-02-22
• Completion: 2024-11-30
• First posted: 2019-10-10
• Last updated: 2025-01-13

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study