NCT04585035

Study to Evaluate D-1553 in Subjects With Solid Tumors

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• 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 single agent and combination treatment 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, Adult
• NSCLC
• CRC

Interventions

Type	Name	Description
DRUG	D-1553	D-1553 is a novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation.
DRUG	D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other	Standard treatment of solid tumor, NSCLC or CRC

Timeline

• Start date: 2020-10-02
• Primary completion: 2024-04-30
• Completion: 2025-12-01
• First posted: 2020-10-14
• Last updated: 2025-03-18

Locations

25 sites across 4 countries: United States, Australia, South Korea, Taiwan

Regulatory

• FDA-regulated drug study