NCT07913360Not yet recruitingPhase 3
GFH375 Plus Cetuximab vs Investigator's Choice of Treatment in KRAS G12D-Mutant Refractory Metastatic Colorectal Cancer
A Multicenter, Open-label, Randomized Controlled Phase III Study Evaluating the Efficacy and Safety/Tolerability of GFH375 in Combination With Cetuximab Versus Investigator's Choice of Treatment in Patients With KRAS G12D Mutant Metastatic Colorectal Cancer Refractory to Oxaliplatin, Fluoropyrimidines, and Irinotecan
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
This is a Phase III trial. All enrolled subjects are patients with metastatic colorectal cancer (mCRC) harboring KRAS G12D mutations who have previously received systemic therapy. The study aims to evaluate and compare the efficacy of GFH375 in combination with cetuximab versus the investigator's choice of treatment in participants with KRAS G12D mutant refractory metastatic colorectal cancer (mCRC).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 368 (estimated)
- First submitted
- 18 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT07913360
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 368
- From 1 Nov 2026 to the primary completion date, 30 Nov 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other malignancy that has progressed or required treatment within 3 years prior to randomization
- Pleural effusion, ascites, or pericardial effusion requiring repeated puncture/drainage (≥2 times/month) or causing significant symptoms within 28 days prior to randomization
- Stroke, transient ischemic attack (TIA), or other severe cerebrovascular disease within 6 months prior to randomization
- Concurrent interstitial lung disease, radiation pneumonitis, or immune-mediated pneumonitis that is clinically significant and requires treatment
- Prior targeted therapy against KRAS or RAS
- Receipt of a live attenuated vaccine within 28 days prior to randomization, or planned vaccination with a live attenuated vaccine during the trial drug treatment period
Other illness
- Clinically significant severe cardiovascular disease
- High-risk factors for bleeding or perforation
- Major acute or chronic infectious disease
- Other poorly controlled systemic disease
- History of organ transplantation or planned organ transplantation
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for study participation
Other
- Known presence of other actionable/targetable driver gene alterations
- Leptomeningeal metastases, spinal cord compression, or active/symptomatic brain metastases
- Pregnant or lactating women
Who the study is looking for
- Willing to participate in the study and provide written informed consent
- Age ≥18 years at the time of signing informed consent; no sex restriction
- Histologically or cytologically confirmed colorectal cancer (CRC)
- KRAS G12D mutation confirmed by the central laboratory
- Disease progression or intolerance during or after prior systemic anticancer therapy
- At least one measurable lesion
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1
- Investigator-assessed life expectancy ≥12 weeks
- Adequate function of major organs
- In the investigator's judgment, the participant is able to communicate effectively, adhere to the scheduled follow-up visits, and comply with the protocol requirements
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.