Trial · NCT05205330
Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers
NCT05205330, Phase 1, Phase 2, Active not recruiting, Rottapharm Biotech
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers. Trials, record NCT05205330. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05205330
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers
- NCT number
- NCT05205330
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 107 participants, estimated
- Lead sponsor
- Rottapharm Biotech
- Conditions
- Refractory Metastatic Colorectal Cancer, Solid Tumor, Metastatic Microsatellite-stable Colorectal Cancer, Mismatch Repair Protein Proficient, Metastatic GI Cancers, Gastric Cancer
- Interventions
- CR6086, AGEN2034
- First posted
- 2022-01-25
- Last updated
- 2025-10-29
- Other registries' IDs
- eudract:2020-002435-29
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability of CR6086 combined with AGEN2034 | From the time of the first dose up to 24 weeks of treatment | Incidence of TEAEs using NCI CTCAE v5.0 |
| Primary | Disease Control rate (DCR) | up to 24 weeks of treatment | Proportion of patients who have achieved CR, PR, or stable disease (SD) per RECIST 1.1 / iRECIST during the Dose Escalation part |
| Primary | Objective Response Rate (ORR) | up to 24 weeks of treatment | Proportion of patients who have achieved CR or PR per RECIST 1.1 / iRECIST during the Expansion part (Phase IIa) |
| Secondary | Disease Control Rate (DCR) | throughout the study | Proportion of patients who have achieved CR, PR, or stable disease (SD) per RECIST 1.1 / iRECIST during the Dose Escalation part |
| Secondary | Objective Response Rate (ORR) | throughout the study | Proportion of patients who have achieved CR or PR per RECIST 1.1 / iRECIST during the Expansion part (Phase IIa) |
| Secondary | Duration Of Response (DOR) | throughout the study, up to 2 years | Time from first documentation of response (CR or PR) until the time of first documentation of disease progression per RECIST 1.1 / iRECIST |
| Secondary | Progression-Free Survival (PFR) | throughout the study, up to 2 years | Time from the first dose of study drugs to the earlier date of assessment of progression per RECIST 1.1 / iRECIST, or death by any cause in the absence of progression |
| Secondary | Progression-Free Survival Rate (PFSR) | throughout the study, up to 2 years | Proportion of patients alive and free of disease progression per RECIST 1.1 / iRECIST at specific timepoints, or death by any cause in the absence of progression |
| Secondary | Overall Survival (OS) | throughout the study, up to 2 years | Time from the first dose of study drugs to the date of death by any cause |
| Secondary | Safety and Tolerability of CR6086 combined with AGEN2034 | throughout the study, up to 2 years | Incidence of TEAEs |
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.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05205330
GET https://conductscience.org/api/trials/v1/NCT05205330/registered