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

Trial Status: Active

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.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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 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
  • Receipt of any biological IMP (e.g., immune checkpoint blockers, antibodies, nanoparticles) within 42 days before the first dose of IP
  • Receipt of St John's Wort within 21 days before the first dose of IP or of another concomitant medication, herbal supplement, or food that is a strong inhibitor or inducer of CYP3A4, CYP2C19, CYP2D6, or P-glycoprotein (PGP) activity within 14 days before the first dose of CT7001
  • Receipt of a blood transfusion (blood or blood products) within 14 days before the first dose of IP
  • Known hypersensitivity to CT7001 or any excipient of the product
  • Impaired hepatic or renal function as demonstrated by any of the following laboratory values:
  • Albumin < 30 g/L
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × the upper limit of normal (ULN)
  • > 5.0 × ULN for patients with liver metastases
  • Total bilirubin > 1.5 × ULN
  • Serum creatinine > 1.5 × ULN
  • Liver function deteriorating in a manner that would likely make the participant meet the AST, ALT, or bilirubin levels specified above at the time of the first dose of IP
  • Other evidence of impaired hepatic synthesis function
  • Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
  • Absolute neutrophil count (ANC) < 1.5 × 10^9/L
  • Platelet count < 100 × 10^9/L
  • Haemoglobin < 90 g/L
  • Persistent (> 4 weeks) severe pancytopenia due to previous therapy rather than to disease (ANC < 0.5 × 10^9/L or platelets < 50 x 10^9/L)
  • Cardiac dysfunction (defined as myocardial infarction within 6 months of study entry, New York Heart Association Class II/III/IV heart failure, unstable angina, unstable cardiac arrhythmias, or left ventricular ejection fraction < 55 percent)
  • Mean resting QT interval corrected for heart rate by the Fridericia formula (QTcF) > 470 msec obtained from 3 electrocardiograms (ECGs) obtained within 5 minutes of each other prior to the first dose
  • Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG (e.g., complete left bundle branch block, third degree heart block). Controlled atrial fibrillation (AF) is permitted
  • Any factor that increases the risk of QTc prolongation or of arrhythmic events (e.g., heart failure, hypokalaemia, congenital long QT syndrome, immediate family history of long QT syndrome or unexplained sudden death under 40 years of age)
  • In the opinion of the Investigator, unlikely to comply with study procedures, restrictions, or requirements
  • A history of haemolytic anaemia or marrow aplasia
  • Has received a live-virus vaccination within 28 days or less of planned treatment start

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: APPROVED

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.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Carrick Therapeutics Limited

  • Primary ID CT7001_001
  • Secondary IDs NCI-2019-08055, 2017-002026-20
  • Clinicaltrials.gov ID NCT03363893