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MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer
The study is a 2-part study of Tinodasertib alone or in combination with Pembrolizumab/Irinotecan in patients with CRC.
Study details:
The study is conducted in 2 parts. First a dose escalation Run-in to identify the Maximum Tolerable Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Tinodasertib to be administered orally as monotherapy and in combination with intravenous pembrolizumab/irinotecan. Part 2 consists of a cohort expansion at the RP2D of Tinodasertib n combination with intravenous pembrolizumab/Irinotecan in patients with locally advanced or metastatic CRC to evaluate clinical activity and safety of Tinodasertib.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-04-14
Primary completion: 2024-09-30
Study completion finish: 2026-10-15
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05462236
Intervention or treatment
DRUG: Tinodasertib
DRUG: Pembrolizumab
DRUG: Irinotecan
Conditions
- • Metastatic Colorectal Cancer
Find a site
Closest Location:
Chris O'Brien Lifehouse
Research sites nearby
Select from list below to view details:
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Prince of Wales Hospital
Wollongong, New South Wales, Australia
Pindara Private Hospital, Gold Coast Cancer Care
Benowa, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Module 1: Arm A: Multiple dose finding cohorts
| DRUG: Tinodasertib
|
EXPERIMENTAL: Module1: Arm B/C: Multiple cohorts of Tinodasertib with fixed dose of pembrolizumab or irinotecan
| DRUG: Tinodasertib
|
EXPERIMENTAL: Module 2: Arm B' and C': Dose Expansion
| DRUG: Tinodasertib
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Adverse events and Serious Adverse events | Incidence and severity of AEs and SAEs. | Approximately 2 years from date of participant enrolment |
Incidence of DLT events and treatment emergent AEs (TEAEs) | Grading of DLTs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 | 1 complete cycle (21 days) |
Objective response rate based on Response Evaluation Criteria in Solid tumors (RECIST) Version 1.1 | Not Specified | Approximately 2 years from date of participant enrolment |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
PK evaluation | Evaluation of Plasma concentrations of AUM001 as monotherapy or in combination with Pembrolizumab/Irinotecan | Approximately 6 months from date of participant enrolment |
Frequently Asked Questions
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