Study of SY-5933 Plus CT-707 in Advanced Solid Tumors With KRAS p.G12C Mutation (NCT06970132) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Study of SY-5933 Plus CT-707 in Advanced Solid Tumors With KRAS p.G12C Mutation
China102 participantsStarted 2025-06
Plain-language summary
This Phase Ib/II, open-label, single-arm study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of SY-5933 tablets combined with CT-707 tablets in patients with advanced solid tumors harboring the KRAS p.G12C mutation. The Phase Ib includes a dose-escalation phase to determine the optimal dosing regimen based on safety and pharmacokinetic data. In Phase II, four cohorts will be enrolled: advanced KRAS p.G12C mutated non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer, and other solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor.
✓. Age ≥ 18 years at the time of informed consent, regardless of gender.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
✓. Life expectancy of at least 12 weeks.
✓. Presence of at least one extracranial target lesion (as defined by RECIST v1.1). Lesions previously treated with radiation therapy may only be considered target lesions if there is clear progression following radiation therapy.
✓. KRAS (G12C) mutation positive. For the Phase Ib dose-escalation phase, participants must have previously undergone standard treatment for advanced tumors. In the Phase II cohorts: Cohort 1 (NSCLC), Cohort 2 (colorectal cancer), Cohort 3 (pancreatic cancer), and Cohort 4 (other solid tumors). In the Phase Ib expansion phase, except for NSCLC, patients with other tumor types must have previously undergone standard treatment for advanced tumors. For Cohort 2-4 of Phase II, initial enrollment will prioritize patients who have received prior standard treatment, but frontline patients may be considered if sufficient efficacy and safety data are collected during Phase Ib or the Phase II study, following review by the Safety Monitoring Committee (SMC) to assess the benefit-risk ratio.
✓. Adequate organ function as defined below:
✓. Liver function:
Exclusion criteria
✕. For patients in the Ib expansion cohort and Phase II, the presence of known major oncogenic driver alterations other than KRAS G12C mutation, such as EGFR, ALK, ROS1, RET, NTRK, KRAS G12D, etc. (Patients with co-mutations may be considered for enrollment after discussion with the investigator).
What they're measuring
1
Incidence of adverse events (AEs) and serious adverse events (SAEs) in KRAS p.G12C Mutant Advanced Solid Tumors in Phase Ib
Timeframe: Up to 24 months
2
Dose-limiting toxicity (DLT) of SY-5933 combined with CT-707 in KRAS p.G12C Mutant Advanced Solid Tumors in Phase Ib
Timeframe: From first dose to end of DLT observation period (approximately 28 days)
3
Objective response rate (ORR) of SY-5933 combined with CT-707 in KRAS p.G12C Mutant Advanced Solid Tumors in Phase II
✕. Prior treatment with a KRAS p.G12C inhibitor.
✕. Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other anti-tumor therapies within 3 weeks prior to the first dose of study drug, except for the following:
✕. Nitrosoureas or mitomycin C administered within 6 weeks prior to the first dose;
✕. Oral fluoropyrimidines and small molecule targeted agents administered within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose.
✕. Receipt of any investigational agents or therapies not yet approved for marketing within 4 weeks prior to the first dose.
✕. Underwent major surgery involving major organs (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to the first dose.
✕. Adverse events from prior anti-cancer therapies have not recovered to Grade ≤1 as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 (except for toxicities assessed by the investigator as posing no safety risk, such as alopecia and Grade 2 peripheral neuropathy).