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CT7001 for Solid Tumors

Phase 1 & 2
Waitlist Available
Led By Matthew Krebs, MBChB PhD
Research Sponsored by Carrick Therapeutics Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening to end of study
Awards & highlights

Summary

This trial tests a new drug, CT7001, for advanced cancers. It focuses on patients with specific types of breast and prostate cancer who may not respond well to standard treatments. The drug works by disrupting cancer cell growth.

Eligible Conditions
  • Advanced Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening to end of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening to end of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability)

Trial Design

6Treatment groups
Experimental Treatment
Group I: Module 4Experimental Treatment1 Intervention
Participants with advanced solid tumours will receive CT7001(samuraciclib) oral monotherapy in a randomized, balanced, single-dose, two-treatment (fed v fasting), two-period, two-sequence crossover study followed by once daily continuous dosing.
Group II: Module 2 Part AExperimental Treatment2 Interventions
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
Group III: Module 1 Part B-2 Castrate resistant prostate Cancer (CRPC) ExpansionExperimental Treatment1 Intervention
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
Group IV: Module 1 Part B-1 Triple-negative breast cancer (TNBC) ExpansionExperimental Treatment1 Intervention
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
Group V: Module 1 Part A Paired Biopsy Breast Cancer Expansion CohortExperimental Treatment1 Intervention
Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
Group VI: Module 1 Part A Multiple ascending dose cohortExperimental Treatment1 Intervention
Participants with advanced solid tumours receive CT7001 (samuraciclib) as oral monotherapy, in ascending dose cohorts, to identify the maximum tolerated dose (MTD), minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3890
CT7001
2017
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Carrick Therapeutics LimitedLead Sponsor
3 Previous Clinical Trials
176 Total Patients Enrolled
Matthew Krebs, MBChB PhDPrincipal InvestigatorThe Christie Hospital, Manchester, UK
~16 spots leftby Sep 2025
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