Trials / Recruiting
RecruitingNCT05462236
MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- AUM Biosciences Pte Ltd · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is a 2-part study of Tinodasertib alone or in combination with Pembrolizumab/Irinotecan in patients with CRC.
Detailed description
The study is conducted in 2 parts. First a dose escalation Run-in to identify the Maximum Tolerable Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Tinodasertib to be administered orally as monotherapy and in combination with intravenous pembrolizumab/irinotecan. Part 2 consists of a cohort expansion at the RP2D of Tinodasertib n combination with intravenous pembrolizumab/Irinotecan in patients with locally advanced or metastatic CRC to evaluate clinical activity and safety of Tinodasertib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tinodasertib | MNK inhibitor |
| DRUG | Pembrolizumab | PD-1 Inhibitor |
| DRUG | Irinotecan | Topoisomerase inhibitor |
Timeline
- Start date
- 2023-04-14
- Primary completion
- 2024-09-30
- Completion
- 2026-10-15
- First posted
- 2022-07-18
- Last updated
- 2024-07-09
Locations
5 sites across 1 country: Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05462236. Inclusion in this directory is not an endorsement.