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

No results posted yet for this study

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

Fulvestrant

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03363893 on ClinicalTrials.gov