NCT04983810

A Study to Investigate Fadraciclib (CYC065), in Subjects With Advanced Solid Tumors and Lymphoma

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Cyclacel Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-part, phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of fadraciclib administered orally BID. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors and lymphoma who have progressed despite having standard therapy or for which no standard therapy exists.

Detailed description

Phase 1 part of the study will consist of a dose-escalation and a dose-finding component . Phase 2 will enroll 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, into 8 groups: Group 1: Endometrial or Ovarian cancer Group 2: Biliary tract cancer Group 3: HCC Group 4: Breast cancer, meeting any of the following criteria: * HER-2 refractory MBC * HR positive, HER-2 negative, MBC post-CDK4/6 inhibitor * Triple-negative breast cancer (TNBC) Group 5: B-cell lymphoma Group 6: T-cell lymphoma (CTCL and PTCL) Group 7: mCRC, including KRAS mutated mCRC Group 8: Basket cohort: Tumor types suspected to have a related mechanism of action such as MCL1, MYC or CCNE amplification/overexpression not included in previous groups.

Conditions

• Solid Tumor, Adult
• Lymphoma

Interventions

Type	Name	Description
DRUG	Fadraciclib	Fadraciclib is a highly selective, orally- and intravenously- available, 2nd generation amino-purine inhibitor of CDK2 and CDK9.

Timeline

• Start date: 2021-07-12
• Primary completion: 2025-04-30
• Completion: 2025-06-30
• First posted: 2021-07-30
• Last updated: 2024-01-25

Locations

4 sites across 3 countries: United States, South Korea, Spain

Regulatory

• FDA-regulated drug study