MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer

Sponsor
AUM Biosciences Pte Ltd
Study ID
NCT05462236
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tinodasertib — DRUG
    MNK inhibitor
  • Pembrolizumab — DRUG
    PD-1 Inhibitor
  • Irinotecan — DRUG
    Topoisomerase inhibitor

Study Details

The study is a 2-part study of Tinodasertib alone or in combination with Pembrolizumab/Irinotecan in patients with CRC.

Key Dates

Start date
Apr 14, 2023
Status verified
Jul 2024
Primary completion
Sep 30, 2024
Completion
Oct 15, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1: Arm A: Multiple dose finding cohorts
    Monotherapy with Tinodasertib administered orally QOD
  • Experimental: Module1: Arm B/C: Multiple cohorts of Tinodasertib with fixed dose of pembrolizumab or irinotecan
    Combination doses with Tinodasertib administered orally QOD with intravenous pembrolizumab at 200mg Q3W or Irinotecan at 180mg/m2 Q2W
  • Experimental: Module 2: Arm B' and C': Dose Expansion
    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 Measure

Adverse events and Serious Adverse events [ Time Frame: Approximately 2 years from date of participant enrolment ]

Central Contacts

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