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a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors
Sponsor: InxMed (Shanghai) Co., Ltd.
Summary
This is a phase 1b/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and antitumor activities of D-1553 in combination with IN10018 in subjects with locally advanced or metastatic solid tumor with KRAS G12C mutation.
Official title: A Phase 1b/II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combined With IN10018 in Subjects With Locally Advanced or Metastatic Solid Tumors With KRAS G12C Mutation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2022-10-12
Completion Date
2028-12-31
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
D1553
D1553 orally taken,600mg twice a day
IN10018(Ifebemtinib)
IN10018 orally taken once daily at approximately the same time each day
Locations (10)
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Hunan Cancer Hospital
Changsha, China
Fujian Cancer Hospital
Fuzhou, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, China
General Hospital Of Eastern Theater Command
Nanjing, China
Renmin Hospital of Wuhan University
Wuhan, China
Xuzhou Central Hospital
Xuzhou, China
Henan Cancer Hospital
Zhengzhou, China
The first Affiliated Hospital of Zhengzhou University
Zhengzhou, China