NCT05379946

Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors

A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Combination With IN10018 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: InventisBio Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2, open label study of D-1553 in combination with IN10018 to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	D-1553	D-1553 is a oral dosed novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation
DRUG	IN10018	IN10018 orally once daily at approximately the same time each day

Timeline

• Start date: 2022-10-12
• Primary completion: 2025-07-01
• Completion: 2025-12-01
• First posted: 2022-05-18
• Last updated: 2025-04-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study