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Study of SY-5933 Plus CT-707 in Advanced Solid Tumors With KRAS p.G12C Mutation

NCT06970132 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-05-14

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

SY-5933

KRAS p.G12C inhibitor

DRUG

CT-707

Focal Adhesion Kinase (FAK) inhibitor

Sponsors & Collaborators

  • Shouyao Holdings (Beijing) Co. LTD

    lead OTHER

Principal Investigators

  • Yinghui Sun, PhD · Shouyao Holdings (Beijing) Co. LTD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06970132 on ClinicalTrials.gov