Clinical trial NCT05756153: A Study of GFH925 in Combination with Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advance Non-small Cell Lung Cancer
Lead sponsor: Genfleet Therapeutics (Shanghai) Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Phase Ib: adverse events
timeFrame: 28 days
measure: Phase II: objective response rate
timeFrame: up to 1 year after last patient in
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: University General Hospital "Attikon"
state: Haidari
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
state: Emilia-Romagna
city: Aviano
country: Italy
facility: IRCCS Centro di Riferimento Oncologico
state: Friuli-Venezia Giulia
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto IRCCS
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena IRCCS
state: Lazio
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardia
city: Candiolo
country: Italy
facility: Candiolo Cancer Institute, FPO-IRCCS
state: Piemonte
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria alle Scotte
state: Toscana
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
state: Veneto
city: Badalona
country: Spain
facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol,Servicio de Oncologia Medica
state: Barcelona
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra, Servicio de Oncologia
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus,Servicio de Oncologia Medica
city: Barcelona
country: Spain
facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol,Servicio de Oncologia Medica
city: Barcelona
country: Spain
facility: Clinica Mi Tres Torres
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga,Oncology Dept
city: Sevilla
country: Spain
facility: Virgen del Rocio University Hospital
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia IVO,Servicio de Oncologia Medica
Study officials:
References: