Actively Recruiting
MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer
Led by AUM Biosciences Pte Ltd · Updated on 2024-07-09
120
Participants Needed
5
Research Sites
182 weeks
Total Duration
On this page
Sponsors
A
AUM Biosciences Pte Ltd
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study is a 2-part study of Tinodasertib alone or in combination with Pembrolizumab/Irinotecan in patients with CRC.
CONDITIONS
Official Title
MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant provides written informed consent for the trial
- At least 18 years old at the time of consent
- Histologically or cytologically confirmed locally advanced or metastatic colorectal cancer
- Enrollment in module 1 regardless of microsatellite stability status; module 2 arm B includes only CRC MSS
- More than 2 prior therapies for colorectal cancer allowed, including prior irinotecan or irinotecan-containing regimens
- CRC MSI-H patients must have progressed on or be resistant to checkpoint inhibitor therapy
- Patients with available molecularly targeted therapies must have been offered such treatments prior to entry
- Eligible for Arm C if failed 5-fluorouracil regimen and progressed after oxaliplatin or irinotecan therapy without targetable driver mutations
- Provided archival or newly obtained tumor tissue sample not previously irradiated
- Measurable disease per RECIST 1.1 criteria
- ECOG performance status of 0 to 1
- Predicted life expectancy of at least 3 months
- Adequate organ function
- HIV-infected participants must be on anti-retroviral therapy with well-controlled infection
- Women of childbearing potential must not be breastfeeding, have negative pregnancy test, and use contraception
- Women of non-childbearing potential must show post-menopausal status
- Non-sterilized male subjects who are sexually active with female partners of childbearing potential must use condoms and spermicide, and avoid sperm donation during the study
You will not qualify if you...
- History of another malignancy within 2 years unless treated with curative intent and relapse risk is less than 5%
- Known active central nervous system metastases or carcinomatous meningitis
- Received systemic anti-cancer therapy or investigational agents within 4 weeks or 5 half-lives before study treatment
- Currently or recently participating in other investigational studies or using investigational devices within 4 weeks prior to study drug
- History of allogeneic tissue or solid organ transplant
- Pregnant or breastfeeding
- Known active Hepatitis B or Hepatitis C infection
- Any condition, therapy, or laboratory abnormality that may interfere with participation or study results
- Known psychiatric or substance abuse disorder interfering with cooperation
- Gastrointestinal disease preventing oral medication intake
- Prior therapy with anti-PD-1, anti-PD-L1, or similar agents discontinued due to severe immune-related adverse events
- Not recovered from radiation toxicities or requiring corticosteroids or history of radiation pneumonitis
- Received live or live-attenuated vaccine within 30 days before first study dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
2
Prince of Wales Hospital
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
3
Pindara Private Hospital, Gold Coast Cancer Care
Benowa, Queensland, Australia, 4217
Actively Recruiting
4
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Actively Recruiting
5
Ballarat Oncology and Haematology
Wendouree, Victoria, Australia, 3355
Actively Recruiting
Research Team
H
HARISH DAVE, MEDICAL
CONTACT
J
JOHN PATAVA, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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