GFH925 combined with Cetuximab for advanced lung cancer with KRAS G12C mutation
A Phase Ib/II, Multi-Center, Open-Label Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH925 in Combination with Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
This study tests if a new drug called GFH925, when combined with Cetuximab, can help people with advanced lung cancer that has a specific KRAS G12C mutation.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genfleet Therapeutics (Shanghai) Inc. Industry-sponsored |
| Drugs / interventions | Cetuximab |
| Locations | 18 sites (Athens, Haidari and 17 other locations) |
| Trial ID | NCT05756153 on ClinicalTrials.gov |
What this trial studies
This Phase Ib/II study evaluates the safety, tolerability, and efficacy of GFH925 in combination with Cetuximab for patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation. The study aims to characterize the pharmacokinetics of GFH925 when used alongside Cetuximab. Participants will be monitored for treatment response and side effects throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed advanced KRAS G12C-mutated NSCLC and a good performance status.
Not a fit: Patients with significant cardiovascular diseases, active CNS metastases, or other serious health conditions 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 NSCLC with the KRAS G12C mutation.
How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient has provided informed consent form (ICF). 2. Males or females aged ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1. 4. Life expectancy \> 3 months judged by the investigator. 5. Have histologically or cytologically confirmed advanced KRAS G12C-mutated NSCLC. 6. Have at least one measurable lesion per RECIST 1.1. 7. Have sufficient organ functions. 8. With toxicities left from prior anti-tumor therapy resolved to baseline or CTCAE Grade 1 (neurotoxicity or alopecia ≤ Grade 2). 9. Women of childbearing potential (WOCBP) and male patients with WOCBP partners must agree to use effective contraception method during the study specified period. Exclusion Criteria: 1. With clinically significant cardiovascular diseases. 2. With active central nervous system (CNS) metastases and/or carcinomatous meningitis. 3. With clinically significant gastrointestinal diseases. 4. With active infections. 5. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion. 6. With uncontrolled systemic diseases, such as hypertension or diabetes. 7. Prior treatment with an inhibitor specific to KRAS G12C. 8. Major surgery within 4 weeks prior to initiation of study treatment. 9. With known allergies to the study drugs or components. 10. Pregnant or lactating females, or female patients intend to become pregnant during participation.
Where this trial is running
Athens, Haidari and 17 other locations
- University General Hospital "Attikon" — Athens, Haidari, Greece (Recruiting)
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS — Bologna, Emilia-Romagna, Italy (Recruiting)
- IRCCS Centro di Riferimento Oncologico — Aviano, Friuli-Venezia Giulia, Italy (Recruiting)
- IOV - Istituto Oncologico Veneto IRCCS — Padova, Friuli-Venezia Giulia, Italy (Recruiting)
- Istituto Nazionale Tumori Regina Elena IRCCS — Roma, Lazio, Italy (Recruiting)
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milano, Lombardia, Italy (Recruiting)
- Candiolo Cancer Institute, FPO-IRCCS — Candiolo, Piemonte, Italy (Recruiting)
- A.O.U. Senese Policlinico Santa Maria alle Scotte — Siena, Toscana, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) — Verona, Veneto, Italy (Recruiting)
- ICO Badalona - Hospital Universitari Germans Trias i Pujol,Servicio de Oncologia Medica — Badalona, Barcelona, Spain (Recruiting)
- Clinica Universidad de Navarra, Servicio de Oncologia — Pamplona, Navarra, Spain (Recruiting)
- Hospital Universitari Dexeus,Servicio de Oncologia Medica — Barcelona, Spain (Recruiting)
- ICO Badalona - Hospital Universitari Germans Trias i Pujol,Servicio de Oncologia Medica — Barcelona, Spain (Recruiting)
- Clinica Mi Tres Torres — Barcelona, Spain (Recruiting)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Regional Universitario de Malaga,Oncology Dept — Málaga, Spain (Recruiting)
- Virgen del Rocio University Hospital — Sevilla, Spain (Recruiting)
- Instituto Valenciano de Oncologia IVO,Servicio de Oncologia Medica — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Therapeutics Genfleet
- Email: GFH925X0201@genfleet.com
- Phone: +86 21 6882 1388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.