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Study of AGEN1571 in Participants With Advanced Solid Tumors
NCT05377528 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2022-07-19 |
| Est. Completion | 2024-12-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05377528
The ClinicalTrials.gov registry entry for NCT05377528 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Agenus, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05377528 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05377528?
The interventions under investigation include: Balstilimab (DRUG), Botensilimab (DRUG), AGEN1571 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05377528?
This trial is sponsored by Agenus, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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