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

Last updated: November 17, 2025
Sponsor: Genfleet Therapeutics (Shanghai) Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

GFH375

Clinical Study ID

NCT06500676
GFH375X1101
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Subjects must voluntarily agree to participate in the trial and sign a writteninformed 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 tumorsharboring KRAS G12D mutation.

  6. Have at least one measurable lesion according to RECIST1.1, and the phase Ia allowsno measurable lesion.

  7. Adequate laboratory parameters during the screening period.

Exclusion

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 Design

Total Participants: 407
Treatment Group(s): 1
Primary Treatment: GFH375
Phase: 1/2
Study Start date:
July 09, 2024
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei 1808722, Anhui 1818058
    China

    Site Not Available

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Biejing, Beijing
    China

    Site Not Available

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing 1816670, Beijing Municipality 2038349
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing 1816670, Beijing Municipality 2038349
    China

    Active - Recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou 1809858, Guangdong 1809935
    China

    Active - Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou 1809858, Guangdong 1809935
    China

    Active - Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital

    Nanning 1799869, Guangxi 1809867
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Haerbin, Heilongjiang 2036965
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou 1784658, Henan 1808520
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha 1815577, Hunan 1806691
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing 1799962, Jiangsu 1806260
    China

    Active - Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning
    China

    Site Not Available

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning
    China

    Active - Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang 2034937, Liaoning 2036115
    China

    Site Not Available

  • The First Affiliated Hospital of China Medical University

    Shenyang 2034937, Liaoning 2036115
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan 1805753, Shandong 1796328
    China

    Active - Recruiting

  • Shanghai Chest Hospital

    Shanhai, Shanghai 201210
    China

    Site Not Available

  • Shanghai Chest Hospital

    Shanhai 7844700, Shanghai Municipality 1796231 201210
    China

    Active - Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan
    China

    Site Not Available

  • Sichuan Cancer Hospital

    Chengdu 1815286, Sichuan 1794299
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjing, Tianjing
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjing 9613729, Tianjing
    China

    Site Not Available

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hang Zhou, Zhejiang
    China

    Site Not Available

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764
    China

    Site Not Available

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou 1808926, Zhejiang 1784764
    China

    Active - Recruiting

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