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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
University General Hospital "Attikon"
Athens, Haidari, Greece
Phase Ib: adverse events
defined as number of patients with treatment emergent AEs
Time frame: 28 days
Phase II: objective response rate
defined as the percent of patients documented a PR/CR
Time frame: up to 1 year after last patient in
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General Hospital of Athens "Alexandra"
Athens, Greece
University General Hospital "Attikon"
Athens, Greece
Bioclinic Thessaloniki
Thessaloniki, Greece
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, Emilia-Romagna, Italy
IRCCS Centro di Riferimento Oncologico
Aviano, Friuli Venezia Giulia, Italy
IOV - Istituto Oncologico Veneto IRCCS
Padova, Friuli Venezia Giulia, Italy
Istituto Nazionale Tumori Regina Elena IRCCS
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, Italy
Candiolo Cancer Institute, FPO-IRCCS
Candiolo, Piedmont, Italy
...and 11 more locations