NCT05358379

A Study to Investigate CYC140, in Subjects With Advanced Solid Tumors and Lymphoma

A Phase 1/2, Open-label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CYC140, an Oral PLK1 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, pharmacokinetics, pharmacodynamics, pharmacogenomics, and efficacy of CYC140 administered orally daily. 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: Bladder cancer Group 2: Breast cancer: Triple-negative breast cancer (TNBC) Group 3: Lung cancer (non-small cell lung cancer \[NSCLC\] and small cell lung cancer \[SCLC\]) Group 4: Hepatocellular carcinoma (HCC) and biliary tract cancer (BTC) Group 5: Metastatic colorectal cancer (mCRC) including KRAS-mutated mCRC Group 6: B-cell lymphoma including diffuse large B-cell lymphoma (DLBCL) Group 7: T-cell lymphoma (cutaneous T-cell lymphoma \[CTCL\] and peripheral T-cell lymphoma \[PTCL\]) Group 8: Basket cohort: tumor types that are suspected to have a related mechanism of action but are not included in previous groups including, esophageal, prostate, ovarian and pancreatic cancers

Conditions

• Solid Tumor, Adult Lymphoma

Interventions

Type	Name	Description
DRUG	CYC140	CYC140 is a highly selective, orally- and intravenously- available, ATP-competitive inhibitor of PLK1.

Timeline

• Start date: 2022-04-14
• Primary completion: 2025-08-01
• Completion: 2025-11-01
• First posted: 2022-05-03
• Last updated: 2024-02-07

Locations

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

Regulatory

• FDA-regulated drug study