A Study of GFH925 in Combination with Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
- Conditions
- Advance Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05756153
- Lead Sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Brief Summary
This is a Phase Ib/II study. The objectives are to evaluate the safety/tolerability and efficacy of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC, to characterize pharmacokinetics (PK) of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- Patient has provided informed consent form (ICF).
- Males or females aged ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
- Life expectancy > 3 months judged by the investigator.
- Have histologically or cytologically confirmed advanced KRAS G12C-mutated NSCLC.
- Have at least one measurable lesion per RECIST 1.1.
- Have sufficient organ functions.
- With toxicities left from prior anti-tumor therapy resolved to baseline or CTCAE Grade 1 (neurotoxicity or alopecia ≤ Grade 2).
- Women of childbearing potential (WOCBP) and male patients with WOCBP partners must agree to use effective contraception method during the study specified period.
- With clinically significant cardiovascular diseases.
- With active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- With clinically significant gastrointestinal diseases.
- With active infections.
- With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.
- With uncontrolled systemic diseases, such as hypertension or diabetes.
- Prior treatment with an inhibitor specific to KRAS G12C.
- Major surgery within 4 weeks prior to initiation of study treatment.
- With known allergies to the study drugs or components.
- Pregnant or lactating females, or female patients intend to become pregnant during participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GFH925+Cetuximab GFH925 - GFH925+Cetuximab Cetuximab -
- Primary Outcome Measures
Name Time Method Phase Ib: adverse events 28 days defined as number of patients with treatment emergent AEs
Phase II: objective response rate up to 1 year after last patient in defined as the percent of patients documented a PR/CR
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
IRCCS Centro di Riferimento Oncologico
🇮🇹Aviano, Friuli-Venezia Giulia, Italy
Virgen del Rocio University Hospital
🇪🇸Sevilla, Spain
Hospital Regional Universitario de Malaga,Oncology Dept
🇪🇸Málaga, Spain
Clinica Mi Tres Torres
🇪🇸Barcelona, Spain
Clinica Universidad de Navarra, Servicio de Oncologia
🇪🇸Pamplona, Navarra, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
ICO Badalona - Hospital Universitari Germans Trias i Pujol,Servicio de Oncologia Medica
🇪🇸Barcelona, Spain
IOV - Istituto Oncologico Veneto IRCCS
🇮🇹Padova, Friuli-Venezia Giulia, Italy
Candiolo Cancer Institute, FPO-IRCCS
🇮🇹Candiolo, Piemonte, Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
🇮🇹Siena, Toscana, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Lombardia, Italy
Hospital Universitari Dexeus,Servicio de Oncologia Medica
🇪🇸Barcelona, Spain
Instituto Valenciano de Oncologia IVO,Servicio de Oncologia Medica
🇪🇸Valencia, Spain
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
🇮🇹Verona, Veneto, Italy
University General Hospital "Attikon"
🇬🇷Athens, Haidari, Greece
Istituto Nazionale Tumori Regina Elena IRCCS
🇮🇹Roma, Lazio, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
🇮🇹Bologna, Emilia-Romagna, Italy