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NCT Number: NCT07259590

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

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.

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Key information

Conditions

Advanced Solid Tumors Cancer CRC (Colorectal Cancer) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site PDAC Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • At least one measurable lesions according to RECIST v1.1
  • Participants receiving Regimen A must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 - 2; participants receiving Regimen B must have an ECOG PS score of 0 - 1.
  • Have sufficient organ function.

Exclusion criteria

  • 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.
  • History of central nervous system (CNS) diseases.
  • Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis requiring treatment.
  • Newly diagnosed deep vein thrombosis or pulmonary embolism within 3 months before the first administration of the study treatment.
  • Presence of uncontrolled or symptomatic pleural effusion, ascites, or pericardial effusion.
  • Having received major surgery within 28 days before the start of the study treatment; having experienced major trauma within 14 days before the start of the study treatment; or planning to undergo major surgery during the study period.
  • Having received radiotherapy within 4 weeks before the start of the study treatment, or having received palliative radiotherapy for bone metastatic lesions within 2 weeks before the start of the study treatment.

Treatment and study plan

GFH375

Combination Product

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

Other names: Cetuximab

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

    Time frame: up to 6 months

    Plasma concentrations of GFH375

  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

    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

    DCR assessed by investigators

  4. TTR

    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

    TTR assessed by investigators

  5. DOR

    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

    DoR assessed by investigators

  6. PFS

    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

    Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by investagors

  7. OS

    Time frame: From the first dose until date of death from any cause, assessed up to 24 months

    Overall Survival

Study contacts

Contact information is provided by the study sponsor or research team.

Junnan Dong

CONTACT

[email protected]

+8615521118409

Yolanda Zeng

CONTACT

[email protected]

+8618073129952

Sponsors and collaborators

Lead sponsor

Genfleet Therapeutics (Shanghai) Inc.

Industry

Registry information

Official study title

A Multicenter, Open-Label, Phase Ib/II Clinical Study to Explore the Efficacy, Pharmacokinetics and Safety/Tolerability of GFH375 in Combination With Cetuximab or Chemotherapy in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutation

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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