Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04836195
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2021-03-29
Brief Title:
Study of PCLX-001 in RR Advanced Solid Malignancies and B-cell Lymphoma
Sponsor:
Pacylex Pharmaceuticals
Organization:
Pacylex Pharmaceuticals
Study Overview
Official Title:
Phase I Trial of PCLX-001 in RelapsedRefractory B-cell Non-Hodgkin Lymphoma and Advanced Solid Malignancies
Status:
RECRUITING
Status Verified Date:
2024-09
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 phase I dose-escalation study of oral PCLX-001 conducted in a multicenter non-randomized open-label non-controlled design The study is comprised of two parts Part A single-agent dose escalation and Part B single-agent expansion cohorts
Detailed Description:
This is a phase I dose-escalation study of oral PCLX-001 conducted in a multicenter non-randomized open-label non-controlled design The study is comprised of two parts Part A single-agent dose escalation and Part B single-agent expansion cohorts
For Part A dose-escalation patients will be enrolled in cohorts of 3 to 6 patients to each dose level A new dose level cannot open to accrual until toxicity has been determined in the preceding dose level ie all patients have completed their first cycle of therapy and data for all patients in that dose level have been reviewed at a safety cohort review meeting Six patients will be treated at the maximum tolerated dose MTD andor recommended phase II dose RP2D If required the MTD cohort may be expanded by an additional 10 patients for further toxicity and response assessment The MTD cohort expansion may be restricted to B-cell lymphoma or advanced solid tumours to ensure there is proper distribution during dose escalation
For Part B single agent expansion cohorts two expansion cohorts N20 each will be opened to determine the preliminary clinical activity of PCLX-001 at the RP2D
Expansion Cohort A Participants with advanced solid malignancies showing preclinical sensitivity or molecular markers of sensitivity to PCLX-001 This includes breast nonsmall cell lung NSCLC small-cell lung SCLC colorectal CRC and bladder cancers
NOW OPEN - Expansion Cohort B Participants with relapsedrefractory RR B-cell lymphoma diffuse large B-cell lymphoma DLBCL high grade B-cell lymphoma HGBL follicular lymphoma FL mantle cell lymphoma MCL and Burkitt lymphoma Transformed large B-cell lymphoma will also be included
For Part A dose-escalation patients will be enrolled in cohorts of 3 to 6 patients to each dose level A new dose level cannot open to accrual until toxicity has been determined in the preceding dose level ie all patients have completed their first cycle of therapy and data for all patients in that dose level have been reviewed at a safety cohort review meeting Six patients will be treated at the maximum tolerated dose MTD andor recommended phase II dose RP2D If required the MTD cohort may be expanded by an additional 10 patients for further toxicity and response assessment The MTD cohort expansion may be restricted to B-cell lymphoma or advanced solid tumours to ensure there is proper distribution during dose escalation
For Part B single agent expansion cohorts two expansion cohorts N20 each will be opened to determine the preliminary clinical activity of PCLX-001 at the RP2D
Expansion Cohort A Participants with advanced solid malignancies showing preclinical sensitivity or molecular markers of sensitivity to PCLX-001 This includes breast nonsmall cell lung NSCLC small-cell lung SCLC colorectal CRC and bladder cancers
NOW OPEN - Expansion Cohort B Participants with relapsedrefractory RR B-cell lymphoma diffuse large B-cell lymphoma DLBCL high grade B-cell lymphoma HGBL follicular lymphoma FL mantle cell lymphoma MCL and Burkitt lymphoma Transformed large B-cell lymphoma will also be included
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None