Study to Evaluate D-1553 in Subjects With Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other: Standard treatment of solid tumor, NSCLC or CRC
Study 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.
Eligibility
Primary outcome measure(s)
- Subject incidence of Dose-limiting toxicities (DLT) — through out the DLT period, approximately 21 days
- Number of subjects participants with adverse events — Through study completion, approximately 3 years
- Plasma concentration of D-1553 as a single agent or in combination with other therapies in subjects wiht advanced or metastatic solid tumors with KRas G12C mutation. — Through study completion, approximately 3 years
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Fresno | California | |
| Research Site | Orange | California | |
| Research Site | San Francisco | California | |
| Research Site | Louisville | Kentucky | |
| Research Site | Detroit | Michigan | |
| Research Site | New York | New York | |
| Research Site | Portland | Oregon | |
| Research Site | Blacktown | New South Wales | |
| Research Site | East Albury | New South Wales | |
| Research Site | Kogarah | New South Wales | |
| Research Site | Waratah | New South Wales | |
| Research Site | Woodville South | South Australia | |
| Research Site | Fitzroy | Victoria | |
| Research Site | Frankston | Victoria | |
| Research Site | Malvern | Victoria | |
| Research Site | Nedlands | Western Australia | |
| Research Site | Seogu | Busan | |
| Research Site | Seongnam-si | Gyeonggi-do | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Tainan | Taiwan | |
| Research Site | Taipei | Taiwan | |
| Research Site | Taipei | Taiwan | |
| Research Site | Taoyuan City | Taiwan |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04585035 on ClinicalTrials.gov ↗ ← All trials in South Korea