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ACTIVE NOT RECRUITING Phase 1

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

NCT03860272 · View on ClinicalTrials.gov ↗

Study Summary

This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.

Interventions

  • DRUG Balstilimab
  • DRUG Botensilimab

Study Locations (18)

California

  • City of Hope Comprehensive Cancer Center — Duarte
  • The Angeles Clinic & Research Institute, a Cedars-Sinai Affiliate — Los Angeles
  • University of Southern California Norris Comprehensive Cancer Center — Los Angeles
  • UCLA Santa Monica Hematology Oncology — Los Angeles
  • Saint John's Cancer Institute — Santa Monica

New York

  • Icahn School of Medicine at Mount Sinai — New York
  • Columbia University Medical Center — New York
  • Memorial Sloan Kettering Cancer Center — New York

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston
  • Dana-Farber Cancer Institute — Boston

Texas

  • MD Anderson Cancer Center — Houston
  • The University of Texas Health Science Center at San Antonio — San Antonio

Arizona

  • HonorHealth Research Institute — Scottsdale

Colorado

  • University of Colorado — Aurora

Connecticut

  • Yale Cancer Center — New Haven

Florida

  • University of Miami Sylvester Comprehensive Cancer Center — Miami

Trial Details

FieldValue
Enrollment Target 499 participants
Start Date 2019-03-20
Est. Completion 2027-12
Phase Phase 1

Sponsor

Agenus

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03860272

The ClinicalTrials.gov registry entry for NCT03860272 describes a study currently listed as active not recruiting. 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 499 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 8 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 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: NCT03860272 reports 18 study locations spanning 10 distinct geographic areas — top geographies include California, New York, Massachusetts. 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 NCT03860272 about?

NCT03860272 is a clinical study titled "Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer". This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (b...

What is the current status of trial NCT03860272?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 499 participants. The study started on 2019-03-20. Estimated completion is 2027-12.

What conditions does trial NCT03860272 study?

This clinical trial studies the following conditions: Prostate Cancer, Ovarian Cancer, Endometrial Cancer, Advanced Cancer, Angiosarcoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03860272?

The interventions under investigation include: Balstilimab (DRUG), Botensilimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03860272?

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 NCT03860272 being conducted?

This trial has 18 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial