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

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening to end of study

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3790

CT7001

2017

Completed Phase 2

~130