A Modular, Multipart, Multiarm, FTiH, Open-label study of CT7001
Research type
Research Study
Full title
A Modular, Multipart, Multiarm, Open-label, Phase I/IIa Study to Evaluate the Safety and Tolerability of CT7001 Alone and in Combination with Anti-cancer Treatments in Patients with Advanced Malignancies
IRAS ID
229294
Contact name
Matthew Krebs
Contact email
Sponsor organisation
Carrick Therapeutics
Eudract number
2017-002026-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 2 months, 0 days
Research summary
The CT7001 Trial is made up of several modules which will run as separate studies. The main aims of the CT7001 trial are to find the safest and most effective dose of CT7001 and then test this dose in different cancers and in combination with other cancer medicines. The single- and multiple-ascending dose part of the Phase 1 study (Module 1A - all solid tumours) has now completed and has determined 360 mg as a safe and biologically active dose for further testing in Module 1B (disease specific cohorts). The Module 1A paired biopsy expansion cohorts in breast cancer is currently open to recruitment with a further cohort in paired biopsy solid tumours planned. A study of the effect of food on the bioavailability of CT7001 (called Module 4) has completed recruitment.
Module 1B-1 TNBC is open and is enrolling patients with metastatic or locally advanced triple-negative breast cancer.
Module 1B-2 CRPC is open and is enrolling patients with Castrate Resistant Prostate Cancer
Module 2A, B and C will enrol metastatic or locally advanced HR+ and HER2- breast cancer in patients who had previously received an aromatase inhibitor and a CDK4/6 inhibitor. Module 2A and 2C are open label CT7001 plus Fulvestrant. Module 2B will be double blind CT7001:placebo (2:1) in combination with Fulvestrant.Further modules are planned in which Module 3 will evaluate CT7001 in patients with AML and Module 5 will investigate CT7001 in combination with anti-PD-1 or anti-PD-L1 monoclonal antibodies in patients with advanced solid malignancies. Additional modules may be added at a later date following approval of the relevant substantial
Bone scans will be required in Modules 1B, 1B-1 TNBC, 2A, 2B and 2C to detect sites of bone metastasis, these bone scans did not apply in Module 1A or Module 4.
1. Peer reviewed scientific journals URL: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbYiIysdXFmH6M2kvPWzcMWA-3DZZaM_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIgrAiUxD0B4BWwt2dC8gYreE0L8GrUPKBeKAefoenJm9INyQvEmuyCVgJEw-2Fvt9l5hVNg19EfwVI1YIfGl8GyQSScjEy3yoy53PA-2FMd1n54m4fabaFufu4AqL2utevXZQG4ZV5wWnsvdH-2FLd7V4-2F98gT9hPTBAfom-2FYsPOOhAKXw-3D-3D&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C5d8a13c43a89479b0f0708dbffe866ee%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638385145848562119%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=kYBKuCbvxG2t93LANyZb%2Bxf%2FxjlQIoBpqDMOycyb610%3D&reserved=0 [rdcu.be]
2. Conference reports:
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- https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbV6Og1r6ssa2BoZpmKAZFyxn7ZG9IKEDouCt54FEK9KDIMeodMmt2Odo7kZZRoM-2FNlepXhJ272QZBoCfu7l6C40-3DF-eW_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIgrAiUxD0B4BWwt2dC8gYr2T7YvdOSzzuNkaELHkBKLMu-2F6LvHXe7h0DKQdSOaiH1fOzlJFnEWTaqu-2F2DwG1AY2TPB6NieylDrexWf1SeAklcr3G1vCJ85kmg4th0FHZpAOeR9dRmN3NkedhGjG2dqEKI9bZe5o11NAvpsX6d9eQ-3D-3D&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C5d8a13c43a89479b0f0708dbffe866ee%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638385145848562119%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=4FG8i6IdGxO0eU8HEGbnf3m3lNiweC1JJw5UvNJt3ec%3D&reserved=0
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REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0311
Date of REC Opinion
31 Oct 2017
REC opinion
Further Information Favourable Opinion