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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 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.

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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

Sponsor

Agenus

24 total trials

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What the Registry Record Tells You About NCT05377528

The ClinicalTrials.gov registry entry for NCT05377528 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (89% lower). The listed sponsor is Agenus, which has 24 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.