A Modular, Multi-Part, Multi-Arm, Phase 1/2 Study to Evaluate the Safety and Tolerability of CT7439 Alone and in Combination With Anticancer Treatments in Participants With Solid Malignancies
Carrick Therapeutics Limited
Summary
This modular, multi-part, multi-arm, Phase 1/2, FIH study allows the evaluation of the safety and tolerability of CT7439, dosed as a monotherapy and in combination with anticancer treatment in participants with solid malignancies.
Description
This study will initially evaluate CT7439 as a monotherapy in participants with locally advanced or metastatic solid malignancies, i.e., Module 1, which includes dose escalation cohort (Part A). \- Part A of Module 1: a First-in Human dose escalation investigating the safety and tolerability of CT7439 to identify the minimum biologically active dose (MBAD) and either maximum tolerated dose (MTD) or maximum feasible dose (MFD) of CT7439 when dosed as monotherapy. SRC, consisting of study investigators and sponsor medical personnel, will be formed to monitor the safety, tolerability, PK, and PD…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Core Inclusion Criteria: * Histopathologically or cytologically confirmed diagnosis of malignant disease evaluable by RECIST v1.1 * Provision of signed written informed consent before any study-related activities, willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures and willing to permit access to stored historical tumor tissue, prior tumor radiological assessments and tumor biomarker data. * ECOG performance status of ≤ 2 with no deterioration over the previous 2 weeks. * Ability to take oral medications and be willing to record…
Interventions
- DrugCT7439 Capsules (0.5 mg, 1mg, 3mg)
CT7439 capsules administered by mouth once a day as monotherapy with a single starting dose of 1mg in Cohort 1 on Cycle 0 Day 1, followed by a minimum 48 hours treatment -free period before continuous daily dosing in cycles of 28 days (Cycle1 onwards) until DLT or disease progression is observed.
Locations (6)
- Research site 03Dallas, Texas
- Research site 01San Antonio, Texas
- Research site 02Fairfax, Virginia
- Research site 05Manchester
- Research site 04Oxford
- Research site 06Sutton