At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 120 target
Drug / intervention
Tinodasertib +2 moredrug
Likely dose
Not stated in record
Key inclusion· 11
- ✓Histologically or cytologically confirmed locally advanced or metastatic colorectal cancer
- ✓At least 18 years of age
- ✓More than 2 prior lines of therapy for CRC
- ✓Archival tumor tissue or newly obtained biopsy from non-irradiated lesion
Key exclusion· 12
- ✕History of another malignancy within 2 years unless curative intent with <5% relapse risk
- ✕Known active CNS metastases or carcinomatous meningitis
- ✕Currently pregnant or breastfeeding
- ✕Known Hepatitis B (HbsAg reactive) or active Hepatitis C (HCV RNA detected)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05462236Phase 2RecruitingUpdate OverdueUpdated 23mo ago · Completion was 21mo agoEnrollment Stalled
Long Recruiting
Update Overdue
A Phase II Open Label, Dose-finding run-in and Cohort Expansion Study to Evaluate the Safety, Tolerability and Effectiveness of Tinodasertib in Combination With Pembrolizumab or Irinotecan in Metastatic Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating Tinodasertib, Pembrolizumab, and 1 other intervention for Metastatic Colorectal Cancer. Currently recruiting, targeting 120 participants across 5 sites.
Signals
Enrollment appears stalled
Detailed Summary
The study is a 2-part study of Tinodasertib alone or in combination with Pembrolizumab/Irinotecan in patients with CRC.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesAustralia
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 2Recruiting
2023202420252026
First PostedJul 2022
Enrollment StartApr 2023
Primary CompletionSep 2024
TodayJul 2026
Study CompletionOct 2026
First PostedJul 18, 2022
Enrollment StartApr 14, 2023
Primary CompletionSep 30, 2024
Study CompletionOct 15, 2026
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.0 years ago
Interventions
Tinodasertibdrug
MNK inhibitor
Pembrolizumabdrug
PD-1 Inhibitor
Irinotecandrug
Topoisomerase inhibitor