A Modular Phase 1/2 Study with CT7439 in Participants with Solid Malignancies
Research type
Research Study
Full title
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
IRAS ID
1010326
Contact name
Sheila O’Mahony
Contact email
Sponsor organisation
Carrick Therapeutics Ltd.
Clinicaltrials.gov Identifier
Research summary
The purpose of the CT7439_001 study, sponsored by Carrick Therapeutics Ltd., is to determine the side effects and dose to use in future clinical trials of the study drug, CT7439, in patients with cancer. The study will also determine how much of the study drug gets into the bloodstream, how quickly the body removes it and how well the study drug works.
CT7439 is a drug which targets an enzyme in the body responsible for the abnormal growth in some cancer cells and is being developed to treat solid tumour cancers. Based on laboratory studies, CT7439 has demonstrated potential if used on its own and also in combination with other anticancer treatments. CT7439 has not been given to people before.
This study will assess the study drug as a therapy on its own (module 1), before being combined with other anticancer treatments (module 2). Patients will be in the study for up to 7 months, however the duration will depend on how the participant responds to study drug. All participants will be followed long term for up to 18 months. After completing the main study, participants who derive benefit from CT7439 may be eligible to continue receiving study drug. Up to 100 participants across two countries (UK and USA) will take part in module 1.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0240
Date of REC Opinion
26 Sep 2024
REC opinion
Further Information Favourable Opinion