A Phase 1/2, Open-label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Fadraciclib (CYC065), an Oral CDK2/9 Inhibitor, in Subjects With Advanced Solid Tumors and Lymphoma

Phase 1

• Conditions: Endometrial cancer, Ovarian cancer, Biliary tract cancer, Hepatocellular carcinoma, B-cell lymphoma, T-cell lymphoma, Metastatic colorectal cancer, Breast cancer (metastatic HER-2 refractory, Hormone receptor +,HER-2 negative, and MBC post-CDK4/6 inhibitor, Triple-negative) Basket cohort: tumor types that are suspected to have a related mechanism of action and are not included in previous groups; MedDRA version: 20.0Level: PTClassification code: 10006187Term: Breast cancer Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10003899Term: B-cell lymphoma Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104; MedDRA version: 27.0Level: PTClassification code: 10052358Term: Colorectal cancer metastatic Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10073071Term: Hepatocellular carcinoma Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10042971Term: T-cell lymphoma Class: 100000004864; MedDRA version: 23.0Level: PTClassification code: 10083232Term: HER2 negative breast cancer Class: 100000004864; MedDRA version: 23.0Level: PTClassification code: 10065430Term: HER2 positive breast cancer Class: 100000004864; MedDRA version: 27.0Level: LLTClassification code: 10027475Term: Metastatic breast cancer Class: 10029104

• Registration Number: CTIS2024-516289-12-00
• Lead Sponsor: Cyclacel Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-30
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

Males or females aged = 18 years or per local regulatory guidelines, Subjects with histological- or cytological-confirmed, advanced cancer who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists, ECOG performance status of 0 or 1, Subjects must have laboratory values as stated in the protocol, Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to starting the study drug. Both males and females must agree to use effective birth control during the study (prior to the first dose and for 6 months after the last dose) if conception is possible during this interval, Subjects must be able to swallow and retain orally administered medication and not have any clinically significant GI abnormalities that may alter the absorption, such as malabsorption syndrome or major resection of the stomach or bowels., Able to agree to and sign the informed consent and to comply with the protocol.

Exclusion Criteria

Subjects with a history of brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases. Subjects with treated brain metastases that are asymptomatic and have been clinically stable for at least 4 weeks will be eligible., Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV). In subjects with a history of HBV, hepatitis B core antibody testing is required and if positive, then HBV DNA testing will be performed, and if positive, the subject will be excluded. For subjects with HCV Ab positive, HCV viral load must be below the limit of quantification., Chemotherapy, biologic therapy, targeted therapy, immunotherapy, extended-field radiotherapy, or investigational agents within 5 half-lives or 3 weeks (whichever is shorter) prior to administration of first dose of study drug on Day 1 or have not recovered from the side effects of such therapy. Patients on a stable dose os fulvestrant prior to enrollment may continue to receive fulvestrant., Major surgery/surgical therapy for any cause within 4 weeks of the first dose, Subjects who have not received vaccines for SARS-COV-2 and have suspected signs and symptoms of COVID-19 or have confirmed COVID- 19., Subjects with a history of another primary malignancy, please see additional details in the protocol., Any other clinically significant acute or chronic medical or psychiatric condition or any laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results. See additional details in the protocol., Diseases that significantly affect GI absorption of fadraciclib, Subjects who have impaired cardiac function or clinically significant cardiac disease, see additional details in the protocol., Presence of active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment, Presence of an active infection requiring intravenous antibiotics, Presence of known history of human immunodeficiency virus-1/2 with uncontrolled viral load and on medications that may interfere with metabolism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified