Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies
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- STATUS
- Recruiting
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- End date
- Dec 28, 2021
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- participants needed
- 200
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- sponsor
- Carrick Therapeutics Limited
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.
Description
Module 1 comprises two sequential parts:
- Part A: First-in-human (FiH) dose escalation investigating the safety and tolerability of CT7001 to identify the minimum biologically active dose (MBAD) and maximum tolerated dose (MTD). Part A also includes a cohort expansion for breast cancer participants only: this includes sequential tumour biopsies for evaluation of pharmacokinetic (PK), pharmacodynamic (PD) and tumour responses. Recruitment is completed.
- Part B: To refine the safety, tolerability, and PK and PD profiles of CT7001 monotherapy in participants with advanced solid malignancies from up to four tumour- specific cohorts, which may include, but is not limited to, triple-negative breast cancer, ovarian cancer, small-cell lung cancer and prostate cancer.
- Part B, Cohort 1, Triple-Negative Breast Cancer (M1B-1 TNBC) treated with CT7001 as monotherapy. Recruitment is currently closed.
- Part B, Cohort 2, Prostate Cancer (M1B-2 CRPC) treated with CT7001 as monotherapy. Recruitment is currently closed.
- Additional Module 1B Cohorts of up to 25 participants each may be added in the future.
- Module 4 is a study investigating the effect of food on the PK of CT7001 monotherapy in participants with advanced solid malignancies. Recruitment is completed.
- Module 2 is a Phase Ib/II, 3-part safety and efficacy study in participants with hormone-receptor positive (HR+ve) and human epidermal growth factor-2 negative (HER2-ve) breast cancer. This module will dose CT7001 in combination with fulvestrant. Module 2 consists of 3 parts - Part A, Part B and Part C. Module 2 Part A is currently open to recruitment. Part B is double-blind, randomized and placebo-controlled Part C will be a crossover from Part B.
Details
| Condition | Advanced Solid Malignancies |
|---|---|
| Treatment | CT7001, CT7001 in combination with fulvestrant |
| Clinical Study Identifier | NCT03363893 |
| Sponsor | Carrick Therapeutics Limited |
| Last Modified on | 28 January 2021 |
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