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

November 17, 2025 updated by: Genfleet Therapeutics (Shanghai) Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
407

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-sen University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • Not yet recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
        • Contact:
          • Jianbo He
    • Heilongjiang
      • Haerbin, Heilongjiang, China
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University Of Science And Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, China
        • Not yet recruiting
        • Liaoning Cancer Hospital & Institute
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
        • Contact:
          • Zuoxin Niu
    • Shanghai Municipality
      • Shanhai, Shanghai Municipality, China, 201210
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • Sichuan Cancer Hospital
        • Contact:
    • Tianjing
      • Tianjing, Tianjing, China
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The First Affiliated Hospital Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GFH375
Drug: GFH375
GFH375 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase Ia:The incidence and severity of AEs and SAEs
Time Frame: 24 months
The incidence and severity of AEs and SAEs
24 months
Phase Ia:The incidence of DLT events
Time Frame: 21 days
The incidence of DLT events
21 days
Phase Ib:The incidence and severity of AEs and SAEs
Time Frame: 24 months
The incidence and severity of AEs and SAEs
24 months
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；
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma concentrations
Time Frame: up to 21 days
Plasma concentrations and PK parameters of GFH375
up to 21 days
Efficacy endpoints
Time Frame: 24 months
Duration of response (DoR)
24 months
Efficacy endpoints
Time Frame: 24 months
Disease control rate (DCR)
24 months
Efficacy endpoints
Time Frame: 24 months
Progression free survival (PFS)
24 months
Efficacy endpoints
Time Frame: 24 months
Overall survival (OS)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genfleet Therapeutics (Shanghai) Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aiping Zhou, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Principal Investigator: Shun Lu, MD, Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GFH375X1101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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