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

NCT06500676 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2025-11-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

GFH375

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

Sponsors & Collaborators

  • Genfleet Therapeutics (Shanghai) Inc.

    lead INDUSTRY

Principal Investigators

  • Shun Lu, MD · Shanghai Chest Hospital

  • Aiping Zhou, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-09
Primary Completion
2028-07-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06500676 on ClinicalTrials.gov