At a glance
ClinicalIndex Comparison RecordPhase 2Active· 140 target
Drug / intervention
D1553 +1 moredrug
Likely dose
D1553 600mgfrom 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 1b/II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combined With IN10018 in Subjects With Locally Advanced or Metastatic Solid Tumors With KRAS G12C Mutation
In Brief
A Phase 2 clinical trial evaluating D1553 and IN10018(Ifebemtinib) for Solid Tumor. Active but no longer recruiting, targeting 140 participants across 10 sites.
Detailed Summary
This is a phase 1b/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and antitumor activities of D-1553 in combination with IN10018 in subjects with locally advanced or metastatic solid tumor with KRAS G12C mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesChina
CollaboratorsInventisBio Co., Ltd
Timeline
Phase 2Active
2023202420252026202720282029
Enrollment StartOct 2022
First PostedDec 2023
TodayJul 2026
Primary CompletionDec 2027
Study CompletionDec 2028
First PostedDec 12, 2023
Enrollment StartOct 12, 2022
Primary CompletionDec 31, 2027
Study CompletionDec 31, 2028
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 2.6 years agoPrimary completion in 1.5 years
Interventions
D1553drug
D1553 orally taken,600mg twice a day
IN10018(Ifebemtinib)drug
IN10018 orally taken once daily at approximately the same time each day