Testing GFH375 in patients with advanced solid tumors that have KRAS G12D mutations

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 study is testing a new drug called GFH375 to see if it can help people with advanced solid tumors that have a specific KRAS G12D mutation.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 407 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Genfleet Therapeutics (Shanghai) Inc. (Industry-sponsored)
• Locations: 20 sites (Hefei, Anhui and 19 other locations)
• Trial ID: NCT06500676 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of GFH375 in patients diagnosed with advanced solid tumors that carry the KRAS G12D mutation. The trial is designed in two phases, Phase I and Phase II, to assess how well the drug works and its effects on patients. Participants will be monitored for their response to the treatment and any side effects experienced during the study.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with advanced solid tumors confirmed to have KRAS G12D mutations.

Not a fit: Patients with active brain metastases or those who have previously been treated with a KRAS G12D inhibitor may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors harboring KRAS G12D mutations.

How similar studies have performed: While this approach is focused on a specific mutation, similar studies targeting KRAS mutations have shown promise, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 19 other locations

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Not_yet_recruiting)
• Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Not_yet_recruiting)
• Harbin Medical University Cancer Hospital — Haerbin, Heilongjiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (Not_yet_recruiting)
• The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
• Shanghai Chest Hospital — Shanhai, Shanghai Municipality, China (Recruiting)
• Sichuan Cancer Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Tianjin Medical University Cancer Institute & Hospital — Tianjing, Tianjing, China (Not_yet_recruiting)
• The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Shun Lu, MD — Shanghai Chest Hospital
• Study coordinator: Yolanda Zeng

Conditions KRAS G12D Mutations; Advanced Solid Tumors