A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations (NCT05005234) | Clinical Trial Compass
CompletedPhase 1/2
A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations
China334 participantsStarted 2021-09-13
Plain-language summary
Phase Ia:
To evaluate the safety/tolerability of GFH925 in subjects with KRAS G12C-mutated advanced solid tumors; To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of GFH925.
Phase Ib:
To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced colorectal cancer or other tumors.
Phase II:
To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced non-small cell lung cancer (NSCLC).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
β. Volunteer to participate in the study and sign the informed consent form.
β. Aged 18 years or older at the time of signing the informed consent form.
β. Subjects must have one measurable lesion (per RECIST 1.1).
β. Subjects with toxic reaction caused by prior anticancer therapy need to have recovered to baseline level (except residual alopecia) or β€ Grade 1 (neurotoxicity β€ Grade 2 acceptable).
β. Eastern Cooperative Oncology Group (ECOG) performance status score (PS) 0 \~ 1.
β. Expected survival β₯ 12 weeks.
β. 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.
β. The investigators deem the subject able to communicate well, attend regular follow-up visits, and complete the study according to the protocol.
Exclusion criteria
β. Significant cardiovascular system disease.
β. Subjects with unstable brain metastases diagnosed by investigators.
β. Significant gastrointestinal diseases, such as intractable hiccup, nausea, vomiting, severe gastrointestinal ulcers, cirrhosis, active gastrointestinal bleeding, or other diseases that affect swallowing tablets or significantly affect oral drug absorption; subjects with severe portal hypertension caused by the presence of Budd-Chiari syndrome or portal emboli in subjects with liver cancer also need to be excluded.
What they're measuring
1
Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs); changes in laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs)
Timeframe: Baseline to 24 Months
2
Phase Ia: Incidence of dose-limiting toxicity (DLT) events
Timeframe: At the end of Cycle 1οΌeach cycle is 21 daysοΌ
3
Phase Ib: ORR per RECIST 1.1
Timeframe: Continuous evaluation during treatment
4
Phase II: ORR assessed by Independent Radiographic Review Committee (IRRC) according to RECIST 1.1