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NCT Number: NCT06500676

A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations

This is a multicenter, open-label, phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.

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Key information

Conditions

KRAS G12D Mutations Advanced Solid Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.
  • ECOG performance status of 0-1.
  • With a life expectancy of ≥12 weeks.
  • With histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation.
  • Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion.
  • Adequate laboratory parameters during the screening period.

Exclusion criteria

  • Active brain metastases.
  • Prior treatment with a KRAS G12D inhibitor.
  • Palliative radiotherapy was completed within 14 days before the first dose.
  • Have poorly controlled or severe cardiovascular disease.
  • Subjects with active hepatitis B or active hepatitis C.
  • Known allergy to the study drug or its components.
  • Pregnant or lactating women.

Treatment and study plan

GFH375

Drug

GFH375 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.

Primary outcomes

  1. Phase Ia:The incidence and severity of AEs and SAEs

    Time frame: 24 months

    The incidence and severity of AEs and SAEs

  2. Phase Ia:The incidence of DLT events

    Time frame: 21 days

    The incidence of DLT events

  3. Phase Ib:The incidence and severity of AEs and SAEs

    Time frame: 24 months

    The incidence and severity of AEs and SAEs

  4. Phase II:Overall response rate (ORR)

    Time frame: 24 months

    For NSCLC cohort： Assessed by BICR according to RECIST 1.1；For other cohorts： Assessed by investigators according to RECIST 1.1；

Secondary outcomes

  1. Plasma concentrations

    Time frame: up to 21 days

    Plasma concentrations and PK parameters of GFH375

  2. Efficacy endpoints

    Time frame: 24 months

    Duration of response (DoR)

  3. Efficacy endpoints

    Time frame: 24 months

    Disease control rate (DCR)

  4. Efficacy endpoints

    Time frame: 24 months

    Progression free survival (PFS)

  5. Efficacy endpoints

    Time frame: 24 months

    Overall survival (OS)

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Genfleet Therapeutics (Shanghai) Inc.

Industry

Registry information

Official study title

An Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GFH375 in Patients With KRAS G12D Mutant Advanced Solid Tumors

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 15, 2024
Registry last updated
Nov 20, 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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