MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Registration Number
- NCT05462236
- Lead Sponsor
- AUM Biosciences Pte Ltd
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Module 1: Arm A: Multiple dose finding cohorts Tinodasertib Monotherapy with Tinodasertib administered orally QOD Module 2: Arm B' and C': Dose Expansion Tinodasertib Combination therapy with Tinodasertib administered orally QOD at RP2D (as determined in Module 1) and either pembrolizumab at 200mg IV Q3W (arm B') or irinotecan 180mg/m2 IV Q2W (arm C') Module1: Arm B/C: Multiple cohorts of Tinodasertib with fixed dose of pembrolizumab or irinotecan Tinodasertib Combination doses with Tinodasertib administered orally QOD with intravenous pembrolizumab at 200mg Q3W or Irinotecan at 180mg/m2 Q2W Module1: Arm B/C: Multiple cohorts of Tinodasertib with fixed dose of pembrolizumab or irinotecan Irinotecan Combination doses with Tinodasertib administered orally QOD with intravenous pembrolizumab at 200mg Q3W or Irinotecan at 180mg/m2 Q2W Module1: Arm B/C: Multiple cohorts of Tinodasertib with fixed dose of pembrolizumab or irinotecan Pembrolizumab Combination doses with Tinodasertib administered orally QOD with intravenous pembrolizumab at 200mg Q3W or Irinotecan at 180mg/m2 Q2W Module 2: Arm B' and C': Dose Expansion Pembrolizumab Combination therapy with Tinodasertib administered orally QOD at RP2D (as determined in Module 1) and either pembrolizumab at 200mg IV Q3W (arm B') or irinotecan 180mg/m2 IV Q2W (arm C') Module 2: Arm B' and C': Dose Expansion Irinotecan Combination therapy with Tinodasertib administered orally QOD at RP2D (as determined in Module 1) and either pembrolizumab at 200mg IV Q3W (arm B') or irinotecan 180mg/m2 IV Q2W (arm C')
- Primary Outcome Measures
Name Time Method Objective response rate based on Response Evaluation Criteria in Solid tumors (RECIST) Version 1.1 Approximately 2 years from date of participant enrolment Adverse events and Serious Adverse events Approximately 2 years from date of participant enrolment Incidence and severity of AEs and SAEs.
Incidence of DLT events and treatment emergent AEs (TEAEs) 1 complete cycle (21 days) Grading of DLTs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
- Secondary Outcome Measures
Name Time Method PK evaluation Approximately 6 months from date of participant enrolment Evaluation of Plasma concentrations of AUM001 as monotherapy or in combination with Pembrolizumab/Irinotecan
Trial Locations
- Locations (5)
Ballarat Oncology and Haematology
🇦🇺Wendouree, Victoria, Australia
Pindara Private Hospital, Gold Coast Cancer Care
🇦🇺Benowa, Queensland, Australia
Cabrini Hospital
🇦🇺Malvern, Victoria, Australia
Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Wollongong, New South Wales, Australia