Solid Tumor, Adult Lymphoma Clinical Trial
Official title:
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
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.
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 ;