CRCPhase 1/2A Phase Ib/IINCT07915921
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
A Phase 1/2 study testing Irinotecan, Oxaliplatin and GFH276 in people with CRC, run by Genfleet Therapeutics (Shanghai) Inc..
Trial summary
This is a Phase Ib/II study to explore the safety/tolerability, efficacy, and pharmacokinetic (PK) characteristics of GFH276 in combination with chemotherapy (+/- bevacizumab) or cetuximab in patients with RAS-mutant metastatic colorectal cancer (mCRC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CRC
- What is being tested?
- Irinotecan, Oxaliplatin and GFH276
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 30 Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- Male or female ≥ 18 years old and ≤75 years old.
- Histologically confirmed metastatic colorectal cancer (mCRC)
- Participants must have experienced disease progression or recurrence during or after prior standard therapy.
- Participants enrolled in this study must provide a written test report confirming RAS mutation or KRAS amplification
- ECOG performance status of 0-1.
Show all 9Show fewer
- With a life expectancy of ≥12 weeks
- Participants must have at least one measurable lesion other than brain lesions per RECIST 1.1.
- Adequate laboratory parameters during the screening period.
Who cannot join
- Active brain metastases.
- Known concomitant other targetable driver gene alterations, including but not limited to HER2, BRAF V600E, etc
- Prior treatment with a PAN-RAS inhibitor.
- 3. Palliative radiotherapy was completed within 28 days before the first dose. 4. Have poorly controlled or severe Gastrointestinal disease. 5. Subjects with active hepatitis B or active hepatitis C. 6. Known allergies to the study drug or its components. 7. Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label, Multicenter, Phase Ib/II Study to Evaluate the Safety/Tolerability, Efficacy, and Pharmacokinetic Characteristics of GFH276 in Combination With Chemotherapy (+/- Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
This is a Phase Ib/II study to explore the safety/tolerability, efficacy, and pharmacokinetic (PK) characteristics of GFH276 in combination with chemotherapy (+/- bevacizumab) or cetuximab in patients with RAS-mutant metastatic colorectal cancer (mCRC).
Read the detailed description
This is a multicenter, open-label, Phase Ib/II study to evaluate the safety/tolerability, efficacy, and PK characteristics of GFH276 in combination with chemotherapy (+/- bevacizumab) or cetuximab in patients with RAS-mutant mCRC. The study includes a Phase Ib dose-escalation part and a Phase II part.
Cohort 1 is an open-label, multicenter study to evaluate GFH276 in combination with FOLFIRI±bev in patients with RAS-mutant metastatic colorectal cancer.
Cohort 2 is an open-label, multicenter study to evaluate GFH276 in combination with mFOLFOX6±bev in patients with RAS-mutant metastatic colorectal cancer.
Cohort 3 is an open-label, multicenter study to evaluate GFH276 in combination with Cetuximab in patients with RAS-mutant metastatic colorectal cancer.
Cohort A is an open-label, multicenter study to evaluate GFH276 in combination with FOLFIRI or mFOLFOX6±bev in patients with RAS-mutant metastatic colorectal cancer.
Cohort B is an open-label, multicenter study to evaluate GFH276 in combination with Cetuximab in patients with RAS-mutant metastatic colorectal cancer.
Cohort C is an open-label, multicenter study to evaluate FOLFIRI or mFOLFOX6+bev in patients with RAS-mutant metastatic colorectal cancer.
- Conditions
- CRC
- Being tested
- Irinotecan, Oxaliplatin, GFH276, Fluorouracil (5-FU), Leucovorin
- Keywords
- metastatic colorectal cancer RAS mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Intravenous irinotecan at a dose of 150 mg/m?
OxaliplatinDrug
Intravenous oxaliplatin at a dose of 85 mg/mr
GFH276Drug
Oral GFH276 administered once daily in combination with other study drugs.
Fluorouracil (5-FU)Drug
Intravenous Fluorouracil at a dose of 2400 mg/m2 via 46-hour infusion.
LeucovorinDrug
Intravenous leucovorin at a dose of 400 mg/m
BevacizumabDrug
at a dose of 5mg/kg
Cetuximab (CRC)Drug
at a dose of500 mg/㎡
| Study group | Role | What they receive |
|---|---|---|
| Phase I:Cohort 1 | Experimental | GFH276 and FOLFIRI±bev IV, Receives: Drug: Irinotecan; Drug: GFH276; Drug: Fluorouracil (5-FU); Drug: Leucovorin; Drug: Bevacizumab |
| Phase I:Cohort 2 | Experimental | GFH276 and mFOLFOX6 and bev IV, Receives: Drug: Oxaliplatin; Drug: GFH276; Drug: Fluorouracil (5-FU); Drug: Leucovorin; Drug: Bevacizumab |
| Phase I:Cohort 3 | Experimental | GFH276 and Cetuximab IV, Receives: Drug: GFH276; Drug: Cetuximab (CRC) |
| Phase II:Cohort A | Experimental | GFH276, oral, QD and FOLFIRI/mFOLFOX6 and bev, IV, Receives: Drug: Irinotecan; Drug: Oxaliplatin; Drug: Fluorouracil (5-FU); Drug: Leucovorin; Drug: Bevacizumab |
| Phase II:Cohort B | Experimental | GFH276, oral, and Cetuximab, IV, Receives: Drug: GFH276; Drug: Cetuximab (CRC) |
| Phase II:Cohort C | Active comparator | FOLFIRI/mFOLFOX6 and / without bev Receives: Drug: Irinotecan; Drug: Oxaliplatin; Drug: Fluorouracil (5-FU); Drug: Leucovorin; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Incidence and severity of AEs and SAEs
Incidence and severity of AEs and SAEs
Measured: up to 24 months
Phase Ib: The incidence of DLT events: The incidence of DLT events
The incidence of DLT events
Measured: First 28 days
Phase II: Objective response rate （ORR）
Overall Response Rate assessed by investigators according to RECIST 1.1
Measured: From first use of medication to disease progression，up to 24 months
Secondary outcomes (8)
ORR:
Overall Response Rate assessed by investigators according to RECIST 1.1
Measured: From first use of medication to disease progression，up to 24 months
OS
Overall Survival
Measured: From first use of medication to disease progression，up to 24 months
Cmax
Maximum plasma concentration
Measured: From first use of medication to C6，up to 6 months
DOR
Duration of Response assessed by investigators
Measured: From first use of medication to disease progression，up to 24 months
DCR
Disease Control Rate
Measured: From first use of medication to disease progression，up to 24 months
TTR
Time To Response assessed by investigators
Measured: From first use of medication to disease progression，up to 24 months
PFS
Progression-Free Survival assessed by investigators according to RECIST 1.1
Measured: From first use of medication to disease progression，up to 24 months
Tmax
Time to Maximum Concentration
Measured: From first use of medication to C6，up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRCStudies of the same condition, open and under way.
- More trials run by Genfleet Therapeutics (Shanghai) Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ruihua xu, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915921
- Sponsor's protocol ID
- GFH276X1202
- Acronym
- A Phase Ib/II
- Status last verified
- Nov 2026
- First submitted
- 29 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase Ib/II Study to Evaluate the Safety/Tolerability, Efficacy, and Pharmacokinetic Characteristics of GFH276 in Combination With Chemotherapy (+/- Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07915921
- Acronym / sponsor ID
- A Phase Ib/II / GFH276X1202
- Conditions
- CRC
- Keywords
- metastatic colorectal cancer RAS mutation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ib/II study to explore the safety/tolerability, efficacy, and pharmacokinetic (PK) characteristics of GFH276 in combination with chemotherapy (+/- bevacizumab) or cetuximab in patients with RAS-mutant metastatic colorectal cancer (mCRC).
Detailed description
This is a multicenter, open-label, Phase Ib/II study to evaluate the safety/tolerability, efficacy, and PK characteristics of GFH276 in combination with chemotherapy (+/- bevacizumab) or cetuximab in patients with RAS-mutant mCRC. The study includes a Phase Ib dose-escalation part and a Phase II part.
Cohort 1 is an open-label, multicenter study to evaluate GFH276 in combination with FOLFIRI±bev in patients with RAS-mutant metastatic colorectal cancer.
Cohort 2 is an open-label, multicenter study to evaluate GFH276 in combination with mFOLFOX6±bev in patients with RAS-mutant metastatic colorectal cancer.
Cohort 3 is an open-label, multicenter study to evaluate GFH276 in combination with Cetuximab in patients with RAS-mutant metastatic colorectal cancer.
Cohort A is an open-label, multicenter study to evaluate GFH276 in combination with FOLFIRI or mFOLFOX6±bev in patients with RAS-mutant metastatic colorectal cancer.
Cohort B is an open-label, multicenter study to evaluate GFH276 in combination with Cetuximab in patients with RAS-mutant metastatic colorectal cancer.
Cohort C is an open-label, multicenter study to evaluate FOLFIRI or mFOLFOX6+bev in patients with RAS-mutant metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase I:Cohort 1 | Experimental | Drug: Irinotecan, Drug: GFH276, Drug: Fluorouracil (5-FU), Drug: Leucovorin, Drug: BevacizumabGFH276 and FOLFIRI±bev IV, |
| Phase I:Cohort 2 | Experimental | Drug: Oxaliplatin, Drug: GFH276, Drug: Fluorouracil (5-FU), Drug: Leucovorin, Drug: BevacizumabGFH276 and mFOLFOX6 and bev IV, |
| Phase I:Cohort 3 | Experimental | Drug: GFH276, Drug: Cetuximab (CRC)GFH276 and Cetuximab IV, |
| Phase II:Cohort A | Experimental | Drug: Irinotecan, Drug: Oxaliplatin, Drug: Fluorouracil (5-FU), Drug: Leucovorin, Drug: BevacizumabGFH276, oral, QD and FOLFIRI/mFOLFOX6 and bev, IV, |
| Phase II:Cohort B | Experimental | Drug: GFH276, Drug: Cetuximab (CRC)GFH276, oral, and Cetuximab, IV, |
| Phase II:Cohort C | Active comparator | Drug: Irinotecan, Drug: Oxaliplatin, Drug: Fluorouracil (5-FU), Drug: Leucovorin, Drug: BevacizumabFOLFIRI/mFOLFOX6 and / without bev |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- Male or female ≥ 18 years old and ≤75 years old.
- Histologically confirmed metastatic colorectal cancer (mCRC)
- Participants must have experienced disease progression or recurrence during or after prior standard therapy.
- Participants enrolled in this study must provide a written test report confirming RAS mutation or KRAS amplification
Key exclusion criteria (4 listed)
- Active brain metastases.
- Known concomitant other targetable driver gene alterations, including but not limited to HER2, BRAF V600E, etc
- Prior treatment with a PAN-RAS inhibitor.
- 3. Palliative radiotherapy was completed within 28 days before the first dose. 4. Have poorly controlled or severe Gastrointestinal disease. 5. Subjects with active hepatitis B or active hepatitis C. 6. Known allergies to the study drug or its components. 7. Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrinotecanIntravenous irinotecan at a dose of 150 mg/m? | Drug | Phase I:Cohort 1, Phase II:Cohort A, Phase II:Cohort C |
| OxaliplatinIntravenous oxaliplatin at a dose of 85 mg/mr | Drug | Phase I:Cohort 2, Phase II:Cohort A, Phase II:Cohort C |
| GFH276Oral GFH276 administered once daily in combination with other study drugs. | Drug | Phase I:Cohort 1, Phase I:Cohort 2, Phase I:Cohort 3, Phase II:Cohort B |
| Fluorouracil (5-FU)Intravenous Fluorouracil at a dose of 2400 mg/m2 via 46-hour infusion. | Drug | Phase I:Cohort 1, Phase I:Cohort 2, Phase II:Cohort A, Phase II:Cohort C |
| LeucovorinIntravenous leucovorin at a dose of 400 mg/m | Drug | Phase I:Cohort 1, Phase I:Cohort 2, Phase II:Cohort A, Phase II:Cohort C |
| Bevacizumabat a dose of 5mg/kg | Drug | Phase I:Cohort 1, Phase I:Cohort 2, Phase II:Cohort A, Phase II:Cohort C |
| Cetuximab (CRC)at a dose of500 mg/㎡ | Drug | Phase I:Cohort 3, Phase II:Cohort B |
Primary outcome
Phase Ib: Incidence and severity of AEs and SAEs
Time frame: up to 24 months
Incidence and severity of AEs and SAEs
Phase Ib: The incidence of DLT events: The incidence of DLT events
Time frame: First 28 days
The incidence of DLT events
Phase II: Objective response rate （ORR）
Time frame: From first use of medication to disease progression，up to 24 months
Overall Response Rate assessed by investigators according to RECIST 1.1
8 secondary outcomes
ORR:
Time frame: From first use of medication to disease progression，up to 24 months
OS
Time frame: From first use of medication to disease progression，up to 24 months
Cmax
Time frame: From first use of medication to C6，up to 6 months
DOR
Time frame: From first use of medication to disease progression，up to 24 months
DCR
Time frame: From first use of medication to disease progression，up to 24 months
TTR
Time frame: From first use of medication to disease progression，up to 24 months
PFS
Time frame: From first use of medication to disease progression，up to 24 months
Tmax
Time frame: From first use of medication to C6，up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ruihua xu, MD principal investigator
Sun Yat-Sen University Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Irinotecan, Oxaliplatin and GFH276 in people with CRC, run by Genfleet Therapeutics (Shanghai) Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yuting peng, PM (13730813620, ytpeng@genfleet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: Incidence and severity of AEs and SAEs (time frame: up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.