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

NCT06500676 · tracked via the Priya Life Science China tracker

Sponsor

Genfleet Therapeutics (Shanghai) Inc.

Phase

Phase 1/2

Started

2024-07-09

Last updated

2025-11-20

Condition(s) studied

KRAS G12D MutationsAdvanced Solid Tumors

Investigational drug(s) / intervention(s)

GFH375

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

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. Male or female ≥ 18 years old and ≤75 years old. 3. ECOG performance status of 0-1. 4. With a life expectancy of ≥12 weeks. 5. With histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation. 6. Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion. 7. Adequate laboratory parameters during the screening period. Exclusion Criteria: 1. Active brain metastases. 2. Prior treatment with a KRAS G12D inhibitor. 3. Palliative radiotherapy was completed within 14 days before the first dose. 4. Have poorly controlled or severe cardiovascular disease. 5. Subjects with active hepatitis B or active hepatitis C. 6. Known allergy to the study drug or its components. 7. Pregnant or lactating women.

Primary outcome measure(s)

Phase Ia:The incidence and severity of AEs and SAEs — 24 months
The incidence and severity of AEs and SAEs
Phase Ia:The incidence of DLT events — 21 days
The incidence of DLT events
Phase Ib:The incidence and severity of AEs and SAEs — 24 months
The incidence and severity of AEs and SAEs
Phase II:Overall response rate (ORR) — 24 months
For NSCLC cohort： Assessed by BICR according to RECIST 1.1；For other cohorts： Assessed by investigators according to RECIST 1.1；

Trial sites (20)

Facility	City	Region	Status
The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	Not Yet Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing Municipality	Recruiting
Peking Union Medical College Hospital	Beijing	Beijing Municipality	Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong	Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	Recruiting
Guangxi Medical University Cancer Hospital	Nanning	Guangxi	Not Yet Recruiting
Harbin Medical University Cancer Hospital	Haerbin	Heilongjiang	Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei	Recruiting
Hunan Cancer Hospital	Changsha	Hunan	Recruiting
Jiangsu Province Hospital	Nanjing	Jiangsu	Recruiting
Liaoning Cancer Hospital & Institute	Shenyang	Liaoning	Not Yet Recruiting
The First Affiliated Hospital of China Medical University	Shenyang	Liaoning	Recruiting
Shandong Cancer Hospital	Jinan	Shandong	Recruiting
Shanghai Chest Hospital	Shanhai	Shanghai Municipality	Recruiting
Sichuan Cancer Hospital	Chengdu	Sichuan	Not Yet Recruiting
Tianjin Medical University Cancer Institute & Hospital	Tianjing	Tianjing	Not Yet Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	Not Yet Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	Recruiting
Zhejiang Cancer Hospital	Hangzhou	Zhejiang	Recruiting

More Genfleet Therapeutics (Shanghai) Inc. trials in China

A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation Recruiting

Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer Recruiting

GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer Starting soon

A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation Starting soon

A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL Recruiting

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Personalized KXV01 Lentinvivo (TCR) Injection as the Therapy for Advanced Solid Tumors Starting soon

A Study of HDM2006 in Patients With Advanced Solid Tumor Recruiting

SKB103 for Injection in Advanced Solid Tumors Recruiting

Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06500676 on ClinicalTrials.gov ↗ ← All trials in China