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

NCT03363893 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: CT7001_0012017-002026-20
• Study Type: interventional
• Target: 124
• Locations: 2 countries
• Sites: 23

Brief 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

Keywords

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability)

  Type, incidence and severity

  Screening to end of study

Secondary Outcomes (3)

• Maximum Plasma Concentration of CT7001 (and Fulvestrant, where applicable) (Cmax)

  After the first dose and during the dosing period

• Area Under the Curve (AUC)

  After the first dose and during the dosing period

• Anti-tumour Activity according to RECIST v1.1

  Baseline until disease progression or withdrawal from the study

Study Arms (5)

Module 1 Part A Multiple ascending dose cohort and Paired Biopsy Breast Cancer Expansion Cohort

EXPERIMENTAL

Module 1 Part A Multiple ascending dose cohort: 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). Following completion of the dose escalation part of Module 1A, participants to receive safe, tolerable and MBAD of CT7001 for the paired biopsy expansion cohort. Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort: 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).

Drug: CT7001

Module 1 Part B-1 Triple-negative breast cancer (TNBC) Expansion

EXPERIMENTAL

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.

Drug: CT7001

Module 1 Part B-2 Castrate resistant prostate Cancer (CRPC) Expansion

EXPERIMENTAL

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.

Drug: CT7001

Module 2 Part A

EXPERIMENTAL

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

Drug: CT7001; Drug: Fulvestrant

Module 4

EXPERIMENTAL

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.

Drug: CT7001

Interventions

CT7001 DRUG

Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression

Also known as: Samuraciclib

Module 1 Part A Multiple ascending dose cohort and Paired Biopsy Breast Cancer Expansion Cohort; Module 1 Part B-1 Triple-negative breast cancer (TNBC) Expansion; Module 1 Part B-2 Castrate resistant prostate Cancer (CRPC) Expansion; Module 2 Part A; Module 4

Fulvestrant DRUG

Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.

Also known as: Faslodex

Module 2 Part A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status 0 or 1 with no deterioration over the previous 2 weeks
• Estimated life expectancy of greater than 12 weeks
• Ability to swallow and retain oral medication
• Women either of non-childbearing potential or of childbearing potential willing to practice effective contraception for the duration of the study and for 6 months (Module 1, Module 4) and 24 months (Module 2) after the last dose of CT7001
• Sexually active male patients must be willing to use condoms with all sexual partners for the duration of the study and for 3 months after the last dose of CT7001.
• Provision of signed and dated, written informed consent

You may not qualify if:

• Any other malignancy that has been active or treated within the past 3 years, with the exception of cervical intraepithelial neoplasia and non-melanoma skin cancer
• Any unresolved toxicity (except alopecia) from prior therapy of ≥ CTCAE Grade 2
• Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring steroids for at least 4 weeks before the first dose of investigational product (IP)
• Refractory nausea and vomiting, chronic gastrointestinal (GI) disease or previous significant bowel resection, with clinically significant sequelae that would preclude adequate absorption of CT7001
• Uncontrolled seizures
• Active infection requiring systemic antibiotic, antifungal, or antiviral medication
• Severe or uncontrolled medical condition or psychiatric condition
• Active bleeding diatheses
• Renal transplant
• Known hepatitis B, hepatitis C, or human immunodeficiency virus infection
• Breastfeeding or pregnancy
• Receipt of systemic cytotoxic treatment for the malignancy within 28 days or ≤ 5 half-lives, whichever is shorter before the first dose of IP
• Receipt of non-cytotoxic treatment for the malignancy within 5 half-lives of the drug before the first dose of IP
• Receipt of corticosteroids (at a dose \> 10 mg prednisone/day or equivalent) within 14 days before the first dose of IP
• Receipt of any small-molecule investigational medicinal product (IMP) within 28 days or ≤ 5 half-lives, whichever is shorter before the first dose of IP

Sponsors & Collaborators

• Carrick Therapeutics Limited: lead

Study Sites (23)

Research Site 54

Tucson, Arizona, 85719, United States

Location

Research Site 31

Beverly Hills, California, 90211, United States

Location

Research Site 37

Tampa, Florida, 33612, United States

Location

Research Site 38

Chicago, Illinois, 60611, United States

Location

Research Site 34

Boston, Massachusetts, 02215, United States

Location

Research Site 47

Cincinnati, Ohio, 45236, United States

Location

Research Site 39

Columbus, Ohio, 43212, United States

Location

Research Site 36

Portland, Oregon, 97239, United States

Location

Research Site 44

Austin, Texas, 78705, United States

Location

Research Site 46

Dallas, Texas, 75246, United States

Location

Research Site 48

Salt Lake City, Utah, 84112, United States

Location

Research Site 33

Salem, Virginia, 24153, United States

Location

Research site 11

Brighton, BN2 5BE, United Kingdom

Location

Research site 5

Cambridge, CB2 0QQ, United Kingdom

Location

Research Site 7

Glasgow, G12 0YN, United Kingdom

Location

Research Site 10

Liverpool, L69 3BX, United Kingdom

Location

Research Site 9

London, SE1 9RT, United Kingdom

Location

Research Site 8

London, W1G 6AD, United Kingdom

Location

Research Site 3

London, W2 1NY, United Kingdom

Location

Research Site 1

Manchester, M20 4BX, United Kingdom

Location

Research Site 4

Manchester, M20 4BX, United Kingdom

Location

Research Site 2

Oxford, OX3 7LE, United Kingdom

Location

Research Site 6

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

• Coombes RC, Howell S, Lord SR, Kenny L, Mansi J, Mitri Z, Palmieri C, Chap LI, Richards P, Gradishar W, Sardesai S, Melear J, O'Shaughnessy J, Ward P, Chalasani P, Arkenau T, Baird RD, Jeselsohn R, Ali S, Clack G, Bahl A, McIntosh S, Krebs MG. Dose escalation and expansion cohorts in patients with advanced breast cancer in a Phase I study of the CDK7-inhibitor samuraciclib. Nat Commun. 2023 Jul 24;14(1):4444. doi: 10.1038/s41467-023-40061-y.

  PMID: 37488191 DERIVED

• Sava GP, Fan H, Coombes RC, Buluwela L, Ali S. CDK7 inhibitors as anticancer drugs. Cancer Metastasis Rev. 2020 Sep;39(3):805-823. doi: 10.1007/s10555-020-09885-8.

  PMID: 32385714 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Fulvestrant

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Matthew Krebs, MBChB PhD

  The Christie Hospital, Manchester, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Modular design

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 6, 2017
• Study Start: November 14, 2017
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (11); US (12)