Trial · NCT05672316
Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy
NCT05672316, Phase 1, Phase 2, Active not recruiting, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy. Trials, record NCT05672316. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05672316
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy
- NCT number
- NCT05672316
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
Advanced Colorectal Adenocarcinoma, Advanced Microsatellite Stable Colorectal Carcinoma, Metastatic Colorectal Adenocarcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Stage III Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8
- Interventions
- Balstilimab, Biospecimen Collection, Botensilimab, Computed Tomography, Regorafenib
- First posted
- 2023-01-05
- Last updated
- 2026-09-01
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase 2 dose of botensilimab, balstilimab, and regorafenib (Phase I) | Cycle 1 (6 weeks) | Will conduct a Simon 2-stage optimal design study. |
| Primary | Incidence of dose limiting toxicities (DLT) (Phase I) | Cycle 1 (6 weeks) | Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. |
| Primary | Overall response rate (ORR) (Phase II) | Up to 2 years | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. |
| Secondary | Incidence of DLTs (Phase I) | Up to 2 years | Graded according to the NCI CTCAE v.5.0. |
| Secondary | ORR (Phase I) | Up to 2 years | Assessed by RECIST 1.1. |
| Secondary | Progression-free survival (PFS) (Phase I) | Time to disease progression/ relapse or death as a result of any cause, assessed up to 2 years | |
| Secondary | Overall survival (OS) (Phase I) | Time to death as a result of any cause, assessed up to 2 years | |
| Secondary | PFS (Phase II) | Time to disease progression or death as a result of any cause, assessed up to 2 years | |
| Secondary | OS (Phase II) | Time to death as a result of any cause, assessed up to 2 years | |
| Secondary | Duration of response (Phase II) | Time to progression or death, starting at the time when a response is experienced, assessed up to 2 years |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT05672316
GET https://conductscience.org/api/trials/v1/NCT05672316/registered