NCT05377528

Study of AGEN1571 in Participants With Advanced Solid Tumors

A Phase 1 Study Investigating AGEN1571 as a Single Agent and in Combination With a PD-1 Inhibitor and/or Botensilimab (AGEN1181) in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Agenus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	AGEN1571	A fully human monoclonal immunoglobulin-like transcript antagonist antibody administered intravenously.
DRUG	Balstilimab	A fully human monoclonal programmed cell death protein 1 antagonist antibody administered intravenously.
DRUG	Botensilimab	A fully human fragment crystallizable-enhanced monoclonal cytotoxic T lymphocyte antigen 4 antibody administered intravenously.

Timeline

• Start date: 2022-07-19
• Primary completion: 2024-12-23
• Completion: 2024-12-23
• First posted: 2022-05-17
• Last updated: 2025-04-30

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study