AzTrials
AzTrials

Colorectal CancerPhase 3NCT07913360

GFH375 Plus Cetuximab vs Investigator's Choice of Treatment in KRAS G12D-Mutant Refractory Metastatic Colorectal Cancer

A Phase 3 study testing GFH375 + Cetuximab, Fruquintinib and Trifluridine and Tipiracil in people with Colorectal Cancer, run by Genfleet Therapeutics (Shanghai) Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
GFH375 + Cetuximab, Fruquintinib and Trifluridine and Tipiracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
368 participants
Where
No sites listed yet
Study dates
Nov 2026to May 2030
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • Other malignancy that has progressed or required treatment within 3 years prior to randomization
  • Known presence of other actionable/targetable driver gene alterations
  • Leptomeningeal metastases, spinal cord compression, or active/symptomatic brain metastases
  • Pleural effusion, ascites, or pericardial effusion requiring repeated puncture/drainage (≥2 times/month) or causing significant symptoms within 28 days prior to randomization
  • Clinically significant severe cardiovascular disease
  • Stroke, transient ischemic attack (TIA), or other severe cerebrovascular disease within 6 months prior to randomization
Show all 15Show fewer
  • High-risk factors for bleeding or perforation
  • Concurrent interstitial lung disease, radiation pneumonitis, or immune-mediated pneumonitis that is clinically significant and requires treatment
  • Major acute or chronic infectious disease
  • Other poorly controlled systemic disease
  • Prior targeted therapy against KRAS or RAS
  • History of organ transplantation or planned organ transplantation
  • 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
  • Pregnant or lactating women
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for study participation

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Fengying PENG contact

+86 21 6882 1388

fypeng@genfleet.com

About this study

Official title: 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

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).

Being tested
GFH375 + Cetuximab, Fruquintinib, Trifluridine and Tipiracil
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GFH375 + CetuximabDrug

    GFH375：600 mg orally, once daily Cetuximab ：500 mg/m² intravenously every 2 weeks

  • FruquintinibDrug

    35 mg/m² orally twice daily (max single dose 80 mg) on Days 1-5 and Days 8-12

  • Trifluridine and TipiracilDrug

    5 mg orally once daily on Days 1-21

Study groups in NCT07913360
Study groupRoleWhat they receive
GFH375 + CetuximabExperimentalNot described
Receives: Drug: GFH375 + Cetuximab
The investigator's choice of treatmentActive comparatorNot described
Receives: Drug: Fruquintinib; Drug: Trifluridine and Tipiracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: Up to approximately 2 years

  2. Overall survival（OS）

    Overall survival

    Measured: Up to approximately three and a half years

Secondary outcomes (11)

  1. Progression-free survival (PFS) assessed by the investigator

    PFS assessed by the investigator according to RECIST v1.1

    Measured: Up to approximately 2 years

  2. Objective response rate (ORR)

    Objective response rate (ORR) assessed by BICR and the investigator according to RECIST v1.1

    Measured: Up to approximately three and a half years

  3. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    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

    Measured: Up to approximately three and a half years

  4. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) leading to treatment modifications

    Incidence and severity of AEs/SAEs leading to treatment discontinuation, treatment interruption, and dose reduction

    Measured: Up to approximately three and a half years

  5. Changes in scores assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    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.

    Measured: Up to approximately three and a half years

  6. Peak Plasma concentration (Cmax) of GFH375

    Peak Plasma concentration (Cmax) of GFH375 following combination treatment

    Measured: Up to approximately three and a half years

  7. Disease control rate (DCR)

    Disease control rate (DCR) assessed by BICR and the investigator according to RECIST v1.1

    Measured: Up to approximately three and a half years

  8. Time to response (TTR)

    Time to response (TTR) assessed by BICR and the investigator according to RECIST v1.1

    Measured: Up to approximately three and a half years

  9. Duration of response (DoR)

    Duration of response (DoR) assessed by BICR and the investigator according to RECIST v1.1

    Measured: Up to approximately three and a half years

  10. Changes in scores assessed by the EORTC Colorectal Cancer-Specific Quality of Life Questionnaire 29 (EORTC QLQ-CR29)

    The EORTC QLQ-CR29 is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. It incorporates 4 multiitem scales and 19 single-items assessing a range of symptoms and problems common among patients with colorectal cancer. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problems.

    Measured: Up to approximately three and a half years

  11. Trough Plasma concentration (Ctrough) of GFH375

    Trough Plasma concentration (Ctrough) of GFH375 following combination treatment

    Measured: Up to approximately three and a half years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionNov 2028 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
368 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07913360
Sponsor's protocol ID
GFH375X1304
Status last verified
Nov 2026
First submitted
18 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GFH375 + Cetuximab, Fruquintinib and Trifluridine and Tipiracil in people with Colorectal Cancer, 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 10 inclusion and 15 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 3 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Fengying PENG (+86 21 6882 1388, fypeng@genfleet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07913360.

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 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in