A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations
An Open-label, Multi-center Phase I/II Clinical Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Effectiveness of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs); changes in laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs)
Time frame: Baseline to 24 Months
Phase Ia: Incidence of dose-limiting toxicity (DLT) events
Time frame: At the end of Cycle 1（each cycle is 21 days）
Phase Ib: ORR per RECIST 1.1
Time frame: Continuous evaluation during treatment
Phase II: ORR assessed by Independent Radiographic Review Committee (IRRC) according to RECIST 1.1
Time frame: Continuous evaluation during treatment
Secondary Endpoints
Phase Ia: PK parameters of GFH925 include but are not limited to: Cmax, Tmax, AUC, t1/2, CL/F and Vd/F
Phase Ia: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS),Overall survival (OS)
Phase Ib and Phase II: DCR, DoR, TTR, PFS per RECIST 1.1, progression-free survival rate at 6 and 12 months, overall survival rate at 12 months
Eligibility Criteria
Inclusion Criteria: 1. Volunteer to participate in the study and sign the informed consent form. 2. Aged 18 years or older at the time of signing the informed consent form. 3. Subjects must have one measurable lesion (per RECIST 1.1). 4. Subjects with toxic reaction caused by prior anticancer therapy need to have recovered to baseline level (except residual alopecia) or ≤ Grade 1 (neurotoxicity ≤ Grade 2 acceptable). 5. Eastern Cooperative Oncology Group (ECOG) performance status score (PS) 0 \~ 1. 6. Expected survival ≥ 12 weeks. 7. Female subjects or male subjects of childbearing potential must take effective contraceptive measures from the time of signing the informed consent form to 30 days after the last dose of GFH925, or to 60 days after the last dose of cetuximab. Female subjects of childbearing potential should have a negative blood pregnancy test within 7 days (inclusive) prior to initiation of study treatment. 8. The investigators deem the subject able to communicate well, …
Read full criteria on CT.gov →✦ Analyst Commentary
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