Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies
NCT03363893 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2025-11-12
Summary
This is a modular, Phase I/II, multicentre study to investigate CT7001 monotherapy in advanced solid malignancies and to further investigate CT7001 as monotherapy or in combination with standard therapy in specific participant groups with Triple Negative Breast Cancer (TNBC), Castrate Resistant Prostate Cancer (CRPC) and in combination with fulvestrant for patients with hormone receptor-positive (HR+ve) / human epidermal growth factor-2 negative (HER2-ve) breast cancer.
Conditions
- Advanced Solid Malignancies
Interventions
- DRUG
-
CT7001
Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
- DRUG
-
Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
Sponsors & Collaborators
-
Carrick Therapeutics Limited
lead INDUSTRY
Principal Investigators
-
Matthew Krebs, MBChB PhD · The Christie Hospital, Manchester, UK
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-14
- Primary Completion
- 2022-12-15
- Completion
- 2022-12-15
- FDA Drug
- Yes
Countries
- United States
- United Kingdom
Study Locations
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