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NCT05377528 · ClinicalTrials.gov registry record · Phase 1

Study of AGEN1571 in Participants With Advanced Solid Tumors

A Phase 1 study of Advanced Solid Tumor, sponsored by Agenus.

Completed
Registry status
Phase 1
Development phase
22
Enrollment target
6
Study locations

NCT05377528: Completed Phase 1 study of Advanced Solid Tumor, sponsored by Agenus.

NCT05377528 is a Phase 1 study of Advanced Solid Tumor that has completed, run by Agenus. The registered enrollment target is 22 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (89% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05377528, a Phase 1 study of Advanced Solid Tumor, has completed, sponsored by Agenus.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target
6
Study locations

Study 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 Studied

Advanced Solid Tumor

Interventions

  • DRUG Balstilimab
  • DRUG Botensilimab
  • DRUG AGEN1571

Study Locations (6)

California

  • USC Norris Comprehensive Cancer Center - Los Angeles

Colorado

  • Sarah Cannon Research Institute at HealthONE - Denver

Florida

  • Florida Cancer Specialists - Sarasota

Massachusetts

  • Dana Farber Cancer Institute - Boston

New York

  • Icahn School of Medicine at Mount Sinai - New York

Rhode Island

  • Lifespan Cancer Institute - Providence

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2022-07-19
Est. Completion 2024-12-23
Phase Phase 1
Agenus

24 total trials

What the finished NCT05377528 record still lists

NCT05377528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 3 interventions - of which Balstilimab is the first listed.

NCT05377528 lists 6 locations in 6 states (California, Colorado, Florida).

Frequently Asked Questions

What is clinical trial NCT05377528 about?

NCT05377528 is a clinical study titled "Study of AGEN1571 in Participants With Advanced Solid Tumors". 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 combina...

What is the current status of trial NCT05377528?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2022-07-19. Estimated completion is 2024-12-23.

What conditions does trial NCT05377528 study?

This clinical trial studies the following conditions: Advanced Solid Tumor.

What interventions are being tested in trial NCT05377528?

The interventions under investigation include: Balstilimab (DRUG), Botensilimab (DRUG), AGEN1571 (DRUG).

Who is sponsoring clinical trial NCT05377528?

This trial is sponsored by Agenus, which has 24 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05377528 being conducted?

This trial has 6 study locations across California, Colorado, Florida, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05377528's enrollment target sits among peer trials

22 181st of 189 higher than 9 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05377528, the US trial registry maintained by the National Library of Medicine. NCT05377528 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.