Trial · NCT03860272
Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
NCT03860272, Phase 1, Active not recruiting, Agenus Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer. Trials, record NCT03860272. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03860272
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
- NCT number
- NCT03860272
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 499 participants, actual
- Lead sponsor
- Agenus Inc.
- Conditions
- Advanced Cancer, Angiosarcoma, Colorectal Cancer Without Liver Metastases, Endometrial Cancer, Fibrolamellar Carcinoma, Non-small-cell Lung Cancer, Ovarian Cancer, Prostate Cancer
- Interventions
- Botensilimab, Balstilimab
- First posted
- 2019-03-01
- Last updated
- 2026-03-30
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Of Treatment-emergent Adverse Events (TEAEs) | First dose through 90 days following last study dose (up to 2 years) | TEAEs will include adverse events of special interest, immune-related adverse events, and adverse drug reactions, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. |
| Primary | DLT Of Botensilimab | First 28 days of treatment | DLTs will include any Grade 2 or greater drug related toxicity for all dose groups, according to NCI CTCAE version 5.0 and protocol specifications. |
| Primary | RP2D Of Botensilimab | First dose through 90 days following last study dose | MTD based on DLT occurrence at DLT period (28 days after first dose) and all TEAEs seen through 90 days following last study dose. |
| Secondary | Objective Response Rate (ORR) According To Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | First dose through up to 2 years | Confirmed ORR will be in the analysis population. |
| Secondary | ORR According to Prostate Cancer Working Group 3 (PCWG3) | First dose through up to 2 years | Confirmed ORR will be in the analysis population. |
| Secondary | Duration Of Response (DOR) According To RECIST 1.1 | From first dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 years) | |
| Secondary | DOR According to PCWG3 | From first dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 years) | |
| Secondary | Disease Control Rate (DCR) According To RECIST 1.1 | First study dose through 24 weeks | DCR will include complete response, partial response, and stable disease. |
| Secondary | DCR According to PCWG3 | First study dose through 24 weeks | DCR will include complete response, partial response, and stable disease. |
| Secondary | Progression-free Survival (PFS) According To RECIST 1.1 | First study dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 years) | PFS time will be assessed. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03860272
GET https://conductscience.org/api/trials/v1/NCT03860272/registered?page=2