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A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation

ConditionsAdvanced Solid Tumors CancerPDACCRC (Colorectal Cancer)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenfleet Therapeutics (Shanghai) Inc.

About this trial

This is a Phase Ib/II clinical study aimed at exploring the safety and efficacy of Regimen A (GFH375 in combination with Cetuximab) and Regimen B (GFH375 in combination with AG) in participants with solid tumors.Phase Ib: To evaluate the safety/tolerability and pharmacokinetic (PK) characteristics of GFH375 in combination with cetuximab or AG in participants with solid tumors, and to explore the efficacy of the combination therapy. Phase II: To evaluate the efficacy, safety/tolerability and PK characteristics of the combination therapy, and to explore the correlation between bio-marker and clinical efficacy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in the study and sign the informed consent form.

Participants receiving Regimen A must be ≥ 18 years old when signing the informed consent form, and participants receiving Arm B must be 18 - 75 years old.

Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors, with KRAS G12D mutation.

Failed standard systemic treatment, or intolerant to standard treatment, or unsuitable for standard treatment, or no standard treatment available.

Disqualifiers

Symptomatic brain metastasis, leptomeningeal metastasis, spinal cord compression, or primary brain tumor.

Presence of known coexisting other cancer driver genes.

Previous or active history of clinically significant cardiovascular dysfunction.

Presence of active infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • GFH375

    Combination product

    GFH375 once daily (QD) .Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.

  • GFH375

    Combination product

    GFH375 once daily (QD). Paclitaxel (albumin-bound) at 125 mg/m² and gemcitabine at 1000 mg/m² will be administered via intravenous infusion on Days 1, 8, and 15 of each 4-week cycle.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Arm A：GFH375 in combination with CetuximabExperimental treatment 1 intervention
Group B: Arm B：GFH375 in combination with AGExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase Ib: Incidence of Dose-Limiting Toxicity (DLT) Events

Time frame
up to 28 days
2

Phase Ib: Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE)

Time frame
From the first dose until 30 days after the last dose, assessed up to 24 months
3

Phase II: Objective Response Rate (ORR) Evaluated by RECIST 1.1

Time frame
From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary outcomes

1

Plasma concentrations of GFH375

Plasma concentrations of GFH375

Time frame
up to 6 months
2

Phase II: Incidence and Severity of AE and SAE

Time frame
From the first dose until 30 days after the last dose, assessed up to 24 months
3

DCR

DCR assessed by investigators

Time frame
From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
4

TTR

TTR assessed by investigators

Time frame
From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genfleet Therapeutics (Shanghai) Inc.

Lead sponsor

Source ClinicalTrials.gov
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