Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577987
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
SafetyEfficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of the Oral Cyclin AB-RxL Inhibitor CID-078 in Patients With Advanced Solid Tumor Malignancies
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a first-in-human multicenter open-label phase 1 study to evaluate safety tolerability and efficacy of CID-078 a Cyclin AB-RxL inhibitor in patients with advanced solid tumors
Detailed Description:
This is a first-in-human multicenter open-label phase 1 study to evaluate safety tolerability and efficacy of CID-078 a Cyclin AB-RxL Arginine-any amino acid-lysine inhibitor in patients with advanced solid tumors The study will be conducted at approximately 10 centers CID-078 will be evaluated as an oral therapeutic This study is divided into two parts Part 1 Dose Escalation and Part 2 Dose Expansion There is also a pilot food effect cohort to evaluate the effect of food on CID-078 pharmacokinetics PK profile
The Dose Escalation Part 1 component of the study will evaluate safety and identify recommended doses for expansion RDEs of CID-078 using a Backfill Bayesian Optimal Interval design Dose escalation will occur sequentially over several dose levels Part 2 is a Dose Expansion in which eligible patients will be treated at the doses selected in Part 1 to evaluate the anti-tumor efficacy of the study drug and further characterize its safety tolerability PK and pharmacodynamics in patients with selected malignancies to be determined prior to opening Part 2
The study consists of a 28-day Screening Period a Treatment Period an End of Treatment EOT Visit and a Safety Follow-up Visit After confirming eligibility patients enter the Treatment Period that consists of repeating 21-day treatment cycles Study drug treatment cycles will continue for as long as the patient does not meet study drug discontinuation criteria Within 7 days of the last dose of study drug or the decision to withdraw from the study patients will undergo an EOT visit and a Safety Follow-Up visit 28 days after the EOT visit
The Dose Escalation Part 1 component of the study will evaluate safety and identify recommended doses for expansion RDEs of CID-078 using a Backfill Bayesian Optimal Interval design Dose escalation will occur sequentially over several dose levels Part 2 is a Dose Expansion in which eligible patients will be treated at the doses selected in Part 1 to evaluate the anti-tumor efficacy of the study drug and further characterize its safety tolerability PK and pharmacodynamics in patients with selected malignancies to be determined prior to opening Part 2
The study consists of a 28-day Screening Period a Treatment Period an End of Treatment EOT Visit and a Safety Follow-up Visit After confirming eligibility patients enter the Treatment Period that consists of repeating 21-day treatment cycles Study drug treatment cycles will continue for as long as the patient does not meet study drug discontinuation criteria Within 7 days of the last dose of study drug or the decision to withdraw from the study patients will undergo an EOT visit and a Safety Follow-Up visit 28 days after the EOT visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None