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

Conditions

Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation

Brief summary

Incidence of adverse events (AEs), serious adverse events (SAEs). Changes in laboratory parameters, vital signs, physical examinations, and electrocardiogram (ECG), Overall response rate (ORR)

Detailed description

Plasma concentration of GFH925, PK parameters of GFH925 including but not limited to Cmax, Tmax, Area under the curve (AUC)0-last, AUC0-inf, T1/2, CL/F and Vd/F post the first dosing, PK parameters of GFH925 including but not limited to Ctrough, Cmax,ss, Cmin,ss, Tmax,ss, AUCtau,ss, T1/2,ss, CL/Fss Vd/Fss and Racc at steady state, Best overall response (BOR), duration of response (DoR), time to response (TTR), progression free survival (PFS) evaluated per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1, and overall survival (OS), Disease control rate (DCR), duration of response (DoR), time to response (TTR), progression free survival (PFS), and overall survival (OS), Incidence of AEs and SAEs. Changes in laboratory parameters, vital signs, physical examinations, and ECG, Ctrough of GFH925 and the concentration of GFH925 at the time near Tmax

Related papers

No related papers found yet.

Interventions

DRUGErbitux 5 mg/mL solution for infusion

DRUGFulzerasib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events (AEs), serious adverse events (SAEs). Changes in laboratory parameters, vital signs, physical examinations, and electrocardiogram (ECG), Overall response rate (ORR)	—

Secondary

Measure	Time frame
Plasma concentration of GFH925, PK parameters of GFH925 including but not limited to Cmax, Tmax, Area under the curve (AUC)0-last, AUC0-inf, T1/2, CL/F and Vd/F post the first dosing, PK parameters of GFH925 including but not limited to Ctrough, Cmax,ss, Cmin,ss, Tmax,ss, AUCtau,ss, T1/2,ss, CL/Fss Vd/Fss and Racc at steady state, Best overall response (BOR), duration of response (DoR), time to response (TTR), progression free survival (PFS) evaluated per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1, and overall survival (OS), Disease control rate (DCR), duration of response (DoR), time to response (TTR), progression free survival (PFS), and overall survival (OS), Incidence of AEs and SAEs. Changes in laboratory parameters, vital signs, physical examinations, and ECG, Ctrough of GFH925 and the concentration of GFH925 at the time near Tmax	—

Measure

Time frame

Plasma concentration of GFH925, PK parameters of GFH925 including but not limited to Cmax, Tmax, Area under the curve (AUC)0-last, AUC0-inf, T1/2, CL/F and Vd/F post the first dosing, PK parameters of GFH925 including but not limited to Ctrough, Cmax,ss, Cmin,ss, Tmax,ss, AUCtau,ss, T1/2,ss, CL/Fss Vd/Fss and Racc at steady state, Best overall response (BOR), duration of response (DoR), time to response (TTR), progression free survival (PFS) evaluated per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1, and overall survival (OS), Disease control rate (DCR), duration of response (DoR), time to response (TTR), progression free survival (PFS), and overall survival (OS), Incidence of AEs and SAEs. Changes in laboratory parameters, vital signs, physical examinations, and ECG, Ctrough of GFH925 and the concentration of GFH925 at the time near Tmax

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Countries

France, Greece, Italy, Spain

Outcome results

None listed