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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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).
. 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).