Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies

  • STATUS
    Recruiting
  • End date
    Dec 28, 2021
  • participants needed
    200
  • sponsor
    Carrick Therapeutics Limited
Updated on 28 January 2021

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 IdentifierNCT03363893
SponsorCarrick Therapeutics Limited
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Advanced Solid Malignancies?
Do you have any of these conditions: Do you have Advanced Solid Malignancies??
Do you have any of these conditions: Do you have Advanced Solid Malignancies??
Do you have any of these conditions: Do you have Advanced Solid Malignancies??
Patients must be able to eat a high-fat meal, as provided by the study site, within a 30-minute period
Histological, radiological or cytological confirmation of an advanced non-haematological malignancy not considered to be appropriate for further standard treatment

Exclusion Criteria

Patients who were unable to fast for at least 10 hours
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