drugset / Trial / NCT05377528

Study of AGEN1571 in Participants With Advanced Solid Tumors

NCT05377528

Phase 1 Completed 22 enrolled Agenus Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, Phase 1, 2-part trial to determine recommended phase 2 doses (RP2Ds) and evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of AGEN1571 both as a monotherapy and in combination with balstilimab (PD-1 inhibitor) and/or botensilimab (2-agent combination or 3-agent combination) in participants diagnosed with advanced solid tumors. Part 1 will be the dose escalation phase to determine the RP2D of AGEN1571 monotherapy or AGEN1571 in combination with balstilimab and/or botensilimab. Part 2 will be the dose expansion phase for specific disease indications. Participants will receive study treatment for up to 2 years, or until any disease progression, unacceptable toxicity, or participant wishes to withdraw consent for any reason.

Timeline

Start
2022-07-19
Primary completion
2024-12-23
Completion
2024-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject AGEN1571 Monoclonal antibody Intravenous
Subject Balstilimab Monoclonal antibody Intravenous
Subject Botensilimab Monoclonal antibody Intravenous

Indications