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A Modular, Multipart, Multi-arm, Open-label, Phase 1/2a Study to Evaluate the Safety and Tolerability of CT7001 Alone and in Combination with Anti-Cancer Treatments in Patients with Advanced Malignancies
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.
Primary Objective, study Part A To determine the recommended Phase 2 dose of CT7001 given in combination with fulvestrant at 500 mg. Primary Objective, study Part B To compare the efficacy of CT7001 given in combination with fulvestrant versus fulvestrant plus placebo. Primary Objective, study Part C To evaluate the efficacy of CT7001 combined with fulvestrant in patients whose disease had progressed on or after fulvestrant plus placebo in Part B of the study
CT7001 (); Faslodex (fulvestrant); Placebo (); fulvestrant ()