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

Source: https://onco.cc/trials/nct05462236/  
OnCo record `nct05462236` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of pembrolizumab and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by AUM Biosciences Pte Ltd, now recruiting.

## Summary

MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT05462236 by AUM Biosciences Pte Ltd, with a registry enrolment figure of 120 participants, started 2023-04-14 and due to reach its primary completion in 2024-09-30. Interventions recorded: Tinodasertib; Pembrolizumab; Irinotecan. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Adverse events and Serious Adverse events; Incidence of DLT events and treatment emergent AEs (TEAEs); Objective response rate based on Response Evaluation Criteria in Solid tumors (RECIST) Version 1.1. Colorectal eligibility wording from the registry: "Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor, and was discontinued from that treatment due to a Grade 3 or higher irAE". Sites: Australia. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT05462236
- Phase: 2
- Setting: 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
- Sponsor: AUM Biosciences Pte Ltd
- Enrolled: 120

## Sources

- ClinicalTrials.gov NCT05462236: https://clinicaltrials.gov/study/NCT05462236

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [FOLFIRI (5-FU, leucovorin, irinotecan)](https://onco.cc/drugs/folfiri/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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