RecruitingPhase 2NCT05462236

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


Sponsor

AUM Biosciences Pte Ltd

Enrollment

120 participants

Start Date

Apr 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AUM001 (an MNK inhibitor) combined with either an immunotherapy drug (pembrolizumab) or a chemotherapy drug (irinotecan) in people with advanced or metastatic colorectal cancer who have already received at least 2 prior treatment lines. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic colorectal cancer - You have already tried at least 2 prior treatments - You have previously received standard chemotherapy regimens - You have measurable disease on imaging - Your performance status and organ function are adequate **You may NOT be eligible if...** - You have untreated brain metastases - You have a known driver mutation with an approved therapy you haven't tried - Your overall health or organ function is too poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTinodasertib

MNK inhibitor

DRUGPembrolizumab

PD-1 Inhibitor

DRUGIrinotecan

Topoisomerase inhibitor


Locations(5)

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Prince of Wales Hospital

Wollongong, New South Wales, Australia

Pindara Private Hospital, Gold Coast Cancer Care

Benowa, Queensland, Australia

Cabrini Hospital

Malvern, Victoria, Australia

Ballarat Oncology and Haematology

Wendouree, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05462236


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