Study to Evaluate D-1553 in Subjects With Solid Tumors

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.

Timeline

Start

2020-10-02

Primary completion

2024-04-30

Completion

2025-12

Publications

• Ruan DY, Wu HX, Xu Y, Munster PN, Deng Y, Richardson G, Yan D, Lee MA, Lee KW, Pan H, Hager S, Li X, Wei S, Hou X, Underhill C, Millward M, Nordman I, Zhang J, Shan J, Han G, Grewal J, Gadgeel SM, Sanborn RE, Huh SJ, Hu X, Zhang Y, Xiang Z, Luo L, Xie X, Shi Z, Wang Y, Zhang L, Wang F, Xu RH. Garsorasib, a KRAS G12C inhibitor, with or without cetuximab, an EGFR antibody, in colorectal cancer cohorts of a phase II trial in advanced solid tumors with KRAS G12C mutation. Signal Transduct Target Ther. 2025 Jun 17;10(1):189. doi: 10.1038/s41392-025-02274-z.

Drugs

Indications