Ignite Creation Date:
2024-05-06 @ 1:44 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04104776
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2019-09-23
Brief Title:
A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas
Sponsor:
Constellation Pharmaceuticals
Organization:
Constellation Pharmaceuticals
Study Overview
Official Title:
A Phase 12 Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas
Status:
RECRUITING
Status Verified Date:
2024-08
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:
First-in-human open-label sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors and lymphomas CPI-0209 is a small molecule inhibitor of EZH2
Detailed Description:
Emerging evidence suggests that EZH2 is overexpressed in many cancer types and has a pivotal role in disease progression This is a Phase 12 open-label multi-center FIH study designed to evaluate the safety and tolerability and preliminary clinical activity of CPI-0209 an EZH21 inhibitor as monotherapy in patients with advanced solid tumors and lymphomas Phase 1 is composed of a CPI-0209 Dose Escalation period in patients with advanced tumors and aims to determine maximum tolerated dose MTD andor recommended Phase 2 dose RP2D of CPI-0209 as monotherapy in patients with advanced tumors
Phase 2 is planned to evaluate safety and tolerability and antitumor activity of CPI-0209 in six disease-specific cohorts M1 to M6 Patients in Cohorts M1 M2 M3 M5 and M6 will be enrolled at 10 to 29 patients per cohort using a Simon 2-stage design Cohort M4 will enroll up to 20 patients with lymphoma in a single-stage The primary aim of Phase 2 part of the study is to evaluate the antitumor activity of CPI-0209 and characterize the safety and tolerability of CPI-0209 as monotherapy in patients with selected tumors
In Phase 2 two additional doses are planned to be evaluated in cohorts M2 and M3 in 2 stages Stage 2a and Stage 2b In Stage 2a approximately 20 patients will be enrolled per cohort and will be randomized 11 to receive 2 prespecified dose levels of CPI-0209 once daily When protocol criteria for initiating Stage 2b will be fulfilled after completion of Stage 2a then Stage 2b will be opened for enrolment of additional 10 patients in one or both dose arms in each of the two cohorts Thus up to 40 patients per cohort M2 and M3 could be enrolled
Phase 2 is planned to evaluate safety and tolerability and antitumor activity of CPI-0209 in six disease-specific cohorts M1 to M6 Patients in Cohorts M1 M2 M3 M5 and M6 will be enrolled at 10 to 29 patients per cohort using a Simon 2-stage design Cohort M4 will enroll up to 20 patients with lymphoma in a single-stage The primary aim of Phase 2 part of the study is to evaluate the antitumor activity of CPI-0209 and characterize the safety and tolerability of CPI-0209 as monotherapy in patients with selected tumors
In Phase 2 two additional doses are planned to be evaluated in cohorts M2 and M3 in 2 stages Stage 2a and Stage 2b In Stage 2a approximately 20 patients will be enrolled per cohort and will be randomized 11 to receive 2 prespecified dose levels of CPI-0209 once daily When protocol criteria for initiating Stage 2b will be fulfilled after completion of Stage 2a then Stage 2b will be opened for enrolment of additional 10 patients in one or both dose arms in each of the two cohorts Thus up to 40 patients per cohort M2 and M3 could be enrolled
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