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

Trial details

Who runs it

Cyclacel Limited

Trial code

EU 2024-516289-12-00

Record updated

2024. december 30.

Original description

Phase 1: To determine the maximum-tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of fadraciclib when administered orally twice daily (BID) or once daily (QD) in 28-day cycles in adult subjects with advanced solid tumors and lymphomaRead full original descriptionShow less

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: To determine the maximum-tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of fadraciclib when administered orally twice daily (BID) or once daily (QD) in 28-day cycles in adult subjects with advanced solid tumors and lymphoma

Phase 2: To evaluate preliminary efficacy of fadraciclib as measured by overall response rate (ORR) in subjects with locally advanced, recurrent, or metastatic, histologically confirmed advanced solid tumors or lymphoma who have failed all standard therapies or for whom standard therapy does not exist

Inclusion: 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: 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 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; Subjects with a history of another primary malignancy, please 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; 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.

EU CTIS 2024-516289-12-00