Trial · NCT07913360
GFH375 Plus Cetuximab vs Investigator's Choice of Treatment in KRAS G12D-Mutant Refractory Metastatic Colorectal Cancer
NCT07913360, Phase 3, Not yet recruiting, Genfleet Therapeutics (Shanghai) Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. GFH375 Plus Cetuximab vs Investigator's Choice of Treatment in KRAS G12D-Mutant Refractory Metastatic Colorectal Cancer. Trials, record NCT07913360. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07913360
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GFH375 Plus Cetuximab vs Investigator's Choice of Treatment in KRAS G12D-Mutant Refractory Metastatic Colorectal Cancer
- NCT number
- NCT07913360
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 368 participants, estimated
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Conditions
- Colorectal Cancer
- Interventions
- GFH375 + Cetuximab, Fruquintinib, Trifluridine and Tipiracil
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) | Up to approximately 2 years | Progression-free survival (PFS) assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Primary | Overall survival（OS） | Up to approximately three and a half years | Overall survival |
| Secondary | Progression-free survival (PFS) assessed by the investigator | Up to approximately 2 years | PFS assessed by the investigator according to RECIST v1.1 |
| Secondary | Objective response rate (ORR) | Up to approximately three and a half years | Objective response rate (ORR) assessed by BICR and the investigator according to RECIST v1.1 |
| Secondary | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | Up to approximately three and a half years | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v6.0 |
| Secondary | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) leading to treatment modifications | Up to approximately three and a half years | Incidence and severity of AEs/SAEs leading to treatment discontinuation, treatment interruption, and dose reduction |
| Secondary | Changes in scores assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Up to approximately three and a half years | The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms. |
| Secondary | Peak Plasma concentration (Cmax) of GFH375 | Up to approximately three and a half years | Peak Plasma concentration (Cmax) of GFH375 following combination treatment |
| Secondary | Disease control rate (DCR) | Up to approximately three and a half years | Disease control rate (DCR) assessed by BICR and the investigator according to RECIST v1.1 |
| Secondary | Time to response (TTR) | Up to approximately three and a half years | Time to response (TTR) assessed by BICR and the investigator according to RECIST v1.1 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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/NCT07913360
GET https://conductscience.org/api/trials/v1/NCT07913360/registered