Treatment of advanced solid tumors with KRAS G12C mutations using GFH925

An Open-label, Multi-center Phase I/II Clinical Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Effectiveness of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

This study is testing a new treatment called GFH925 to see if it is safe and effective for people with advanced solid tumors that have KRAS G12C mutations, including those with advanced colorectal cancer and non-small cell lung cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Drugs / interventions: cetuximab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05005234 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of GFH925 in patients with advanced solid tumors harboring KRAS G12C mutations. It consists of three phases: Phase Ia focuses on determining the maximum tolerated dose and recommended Phase 2 dose, while Phase Ib assesses the efficacy of GFH925 in advanced colorectal cancer and other tumors. Phase II specifically targets the efficacy of GFH925 in advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutations.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with measurable KRAS G12C-mutated advanced solid tumors.

Not a fit: Patients without KRAS G12C mutations or those with significant comorbidities that affect treatment tolerance 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 that have KRAS G12C mutations.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Volunteer to participate in the study and sign the informed consent form.
2. Aged 18 years or older at the time of signing the informed consent form.
3. Subjects must have one measurable lesion (per RECIST 1.1).
4. Subjects with toxic reaction caused by prior anticancer therapy need to have recovered to baseline level (except residual alopecia) or ≤ Grade 1 (neurotoxicity ≤ Grade 2 acceptable).
5. Eastern Cooperative Oncology Group (ECOG) performance status score (PS) 0 \~ 1.
6. Expected survival ≥ 12 weeks.
7. Female subjects or male subjects of childbearing potential must take effective contraceptive measures from the time of signing the informed consent form to 30 days after the last dose of GFH925, or to 60 days after the last dose of cetuximab. Female subjects of childbearing potential should have a negative blood pregnancy test within 7 days (inclusive) prior to initiation of study treatment.
8. The investigators deem the subject able to communicate well, attend regular follow-up visits, and complete the study according to the protocol.

Exclusion Criteria:

1. Significant cardiovascular system disease.
2. Subjects with unstable brain metastases diagnosed by investigators.
3. Significant gastrointestinal diseases, such as intractable hiccup, nausea, vomiting, severe gastrointestinal ulcers, cirrhosis, active gastrointestinal bleeding, or other diseases that affect swallowing tablets or significantly affect oral drug absorption; subjects with severe portal hypertension caused by the presence of Budd-Chiari syndrome or portal emboli in subjects with liver cancer also need to be excluded.
4. Presence of serious acute or chronic infections.
5. Pregnant or lactating women.
6. Known allergy to the study drug or any component of its formulation.
7. Other conditions that the investigators consider inappropriate for participation in this study.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Bingo Min

Conditions KRAS G12C