Ignite Creation Date:
2024-05-06 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05358379
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2022-04-19
Brief Title:
A Study to Investigate CYC140 in Subjects With Advanced Solid Tumors and Lymphoma
Sponsor:
Cyclacel Pharmaceuticals Inc
Organization:
Cyclacel Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 12 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:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 2-part phase 12 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None