MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer
NCT ID: NCT05462236
Last Updated: 2024-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2023-04-14
2026-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Module 1: Arm A: Multiple dose finding cohorts
Monotherapy with Tinodasertib administered orally QOD
Tinodasertib
MNK inhibitor
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
Tinodasertib
MNK inhibitor
Pembrolizumab
PD-1 Inhibitor
Irinotecan
Topoisomerase inhibitor
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')
Tinodasertib
MNK inhibitor
Pembrolizumab
PD-1 Inhibitor
Irinotecan
Topoisomerase inhibitor
Interventions
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Tinodasertib
MNK inhibitor
Pembrolizumab
PD-1 Inhibitor
Irinotecan
Topoisomerase inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects are at least 18 years of age at the time of signing the Informed Consent Form
3. Subjects with histologically or cytologically confirmed diagnosis of locally advanced or metastatic CRC.
1. Locally determined histological diagnosis is acceptable for study entry in Module 1.
2. Subjects can be enrolled in module 1 regardless of microsatellite stability status.
3. Only subjects with CRC MSS will be enrolled in module 2, arm B'.
4. Subjects who have had \>2 lines of prior therapy for their CRC.
1. Prior use of irinotecan or irinotecan containing regimens is permitted
2. CRC MSI-H patients should have been treated with a checkpoint inhibitor and have progressed on such therapy or found to be resistant, refractory or intolerant to the checkpoint inhibitor
3. Patients with an available molecularly targeted therapy such as antibodies targeting VEGF/R, EGFR, encorafenib/cetuximab, prior to study entry. Additionally, patients with driver mutations for which an FDA approved therapy is available such as BRAF V600E, HER2 or NTRK should have been offered such therapy prior to study entry.
4. CRC subjects will be eligible to enrol in Arm C' if they have failed an established 5-fluorouracil containing regimen and have progressed after oxaliplatin based or irinotecan-based combination therapy and do not have a driver mutation for which there is an approved targeted therapy.
5. Subject must have provided archival tumor tissue sample or newly obtained core or excisional or punch needle biopsy of a tumor lesion not previously irradiated.
6. Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiologist.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
8. Have a predicted life expectancy of greater or equal to 3 months.
9. Have adequate organ function
10. HIV infected participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease
11. Women of childbearing potential must not be breastfeeding and must have a negative serum or urine pregnancy test. Must be willing to use an adequate method of contraception.
12. Women of non-childbearing potential: Evidence of post-menopausal status is required.
13. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom plus spermicide. Male subjects should refrain from sperm donation throughout this period.
Exclusion Criteria
2. Has known active CNS metastases and/or carcinomatous meningitis.
3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter prior to study treatment.
4. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
5. Has had an allogeneic tissue/solid organ transplant.
6. Pregnant or breastfeeding
7. Has a known history or Hepatitis B (defined as HbsAg reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection.
8. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
9. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
10. Gastrointestinal (GI) tract disease causing the inability to take oral medication.
11. 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.
12. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, or have had history of radiation pneumonitis.
13. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
AUM Biosciences Pte Ltd
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Kate Mahon, MD
Role: primary
Morteza Aghmesheh, Prof
Role: primary
Shehara Mendis, MD
Role: primary
George Kannourakis, Prof
Role: primary
Other Identifiers
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KEYNOTE-D65
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-D65
Identifier Type: OTHER
Identifier Source: secondary_id
AUM001-2001-MK3475-D65
Identifier Type: -
Identifier Source: org_study_id
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