At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 225 enrolled
Drug / intervention
D-1553drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating D-1553 for NSCLC. Completed, enrolled 225 participants across 2 sites.
Detailed Summary
This is a phase 1/2, open label study of D-1553 single agent 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 NSCLC with KRasG12C mutation
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNSCLC
CountriesChina
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
Enrollment StartMar 2021
First PostedMay 2022
Primary CompletionNov 2023
Study CompletionMay 2024
TodayJul 2026
First PostedMay 20, 2022
Enrollment StartMar 16, 2021
Primary CompletionNov 17, 2023
Study CompletionMay 17, 2024
TodayJul 1, 2026
Enrollment to primary: 2.7 yearsPosted 4.1 years ago
Interventions
D-1553drug
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.