Trial · NCT06936527
XS-03 in Combination With FOLFOX or FOLFIRI and Bevacizumab for Treatment of Metastatic Colorectal Cancer Patients With RAS Mutation
NCT06936527, Phase 1, Phase 2, Enrolling by invitation, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. XS-03 in Combination With FOLFOX or FOLFIRI and Bevacizumab for Treatment of Metastatic Colorectal Cancer Patients With RAS Mutation. Trials, record NCT06936527. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06936527
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- XS-03 in Combination With FOLFOX or FOLFIRI and Bevacizumab for Treatment of Metastatic Colorectal Cancer Patients With RAS Mutation
- NCT number
- NCT06936527
- Status
- Enrolling by invitation
- Phases
- Phase 1, Phase 2
- Enrollment
- 102 participants, estimated
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
- Conditions
- Colorectal Cancer, Metastatic Colorectal Cancer With RAS Mutation
- Interventions
- Drug: XS-03, Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI, Drug: XS-03, Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI
- First posted
- 2025-04-20
- Last updated
- 2026-09-25
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Number of participants with Dose-limiting Toxicities (DLTs) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab | up to day 28 | Dose-limiting toxicities were defined as events related to XS-03 that were considered an adverse reaction or suspected adverse reaction during the first cycle of treatment |
| Primary | Phase 1b: Determine the Maximum Tolerated Dose (MTD) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab | up to day 28 | MTD is defined as at most 1 patient out of 6 experiencing DLT |
| Primary | Phase 2: Objective Response Rate (ORR) of two experimental arms and comparator arm | up to 18 months after first dose of last patient | Defined as the percentage of participants that achieve a best overall response of complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria) |
| Secondary | Phase 1b: Objective Response Rate (ORR) of all treated participants | up to 18 months after first dose of last patient | |
| Secondary | Duration of response (DOR) of all treated participants | up to 18 months after first dose of last patient | Duration of response defined as time from when response was first documented until first documented disease progression or death, whichever occurs first. |
| Secondary | Progression-free survival (PFS) of treated participants | up to 18 months after first dose of last patient | as determined based on RECIST version 1.1 criteria |
| Secondary | Overall survival (OS) of treated participants | up to 18 months after first dose of last patient | Time in months from date of first dose for phase 1b and randomization for phase 2 to death due to any cause |
| Secondary | Number of Participants With Adverse Events (AEs) of treated participants | up to 28 days after last dose of study drug | The severity of each AE will be graded using the Common Terminology Criteria for Adverse Events (CTCAE). |
| Secondary | Number of Participants With Clinically Significant Change From Baseline in safety monitoring | up to 28 days after last dose of study drug | |
| Secondary | Number of Participants With dose adjustment | up to 28 days after last dose of study drug | AE associated with dose reduction, interruption and discontinuation |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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.
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/NCT06936527
GET https://conductscience.org/api/trials/v1/NCT06936527/registered