Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
Public ClinicalTrials.gov record NCT03860272. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination With AGEN2034 (Balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03860272
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 499 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 20, 2019 (Actual)
- Primary completion
- Jan 13, 2025 (Actual)
- Completion
- Dec 2027 (Estimated)
- Last update posted
- Mar 30, 2026
2019 – 2027
United States locations
- U.S. sites
- 17
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| The Angeles Clinic & Research Institute, a Cedars-Sinai Affiliate | Los Angeles | California | 90025 | — |
| University of Southern California Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UCLA Santa Monica Hematology Oncology | Los Angeles | California | 90095 | — |
| Saint John's Cancer Institute | Santa Monica | California | 90404 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Yale Cancer Center | New Haven | Connecticut | 06520 | — |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Providence Portland Cancer Center | Portland | Oregon | 97213 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03860272, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 30, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03860272 live on ClinicalTrials.gov.