Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT06970132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of SY-5933 Plus CT-707 in Advanced Solid Tumors With KRAS p.G12C Mutation
Sponsor:
Shouyao Holdings (Beijing) Co. LTD
Organization:
Study Overview
Official Title:
A Phase Ib/II, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SY-5933 Tablets in Combination With CT-707 Tablets in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
This is an open-label, single-arm Phase Ib/II trial to assess the combination of SY-5933 and CT-707 in KRAS p.G12C mutated advanced solid tumors. In Phase Ib, six patients will receive 800 mg of SY-5933 and 600 mg of CT-707 once daily (QD) in a dose-escalation design, with dose adjustments based on safety, pharmacokinetic and efficacy data. The Ib expansion phase will further investigate the most promising dose/frequency combinations. In Phase II, four cohorts will be treated: advanced NSCLC, colorectal cancer, pancreatic cancer, and other solid tumors with KRAS p.G12Cmutation. Efficacy will be evaluated through interim analyses based on objective response rate. Patients will be treated until disease progression, unacceptable toxicity, death, or study completion.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: