Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05484011
Status:
TERMINATED
Last Update Posted:
2024-04-10
First Post:
2022-07-15
Brief Title:
A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Sponsor:
HiberCell Inc
Organization:
HiberCell Inc
Study Overview
Official Title:
P1b Open-Label Safety Tolerability Efficacy Study of a Soluble Beta-glucan Odetiglucan in Combination w a CD40 Agonist CDX-1140 in Patients w Metastatic Pancreatic Adenocarcinoma Whose Disease Did Not Progress During 1st-Line Chemo
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this maintenance therapy study is to identify the maximum tolerated dose MTD and or recommended Phase 2 dose RP2D and evaluate the safety tolerability and dose-limiting toxicities DLTs of odetiglucan in combination with CDX-1140 in patients with metastatic PDAC with evidence of response or stable disease following a minimum of 16 and no more than 32 weeks of chemotherapy
Up to 45 patients will be enrolled and dosed 30 patients in Part A and 15 in Part B
Up to 45 patients will be enrolled and dosed 30 patients in Part A and 15 in Part B
Detailed Description:
This is a multiple institution open-label 2-part Phase 1b study to determine the MTD and or RP2D safety tolerability and preliminary efficacy of the combination of odetiglucan and CDX-1140 for the treatment of patients with metastatic PDAC with evidence of response or stable disease during a minimum of 16 and no more than 32 weeks of therapy immediately prior to study enrollment Part A will identify the MTD and or RP2D in two cohorts of patients enrolled per ABA status Cohort 1ABA and Cohort 2ABA- and Part B will assess an alternative dosing regimen of RP2D in an anti-beta glucan antibody ABA ABA- or ABA mixed population ABA and ABA- based on observations in Part A
Product Odetiglucan and CDX-1140 5 ProtocolAmendment No PGG-PAN2111 Amd0010 Confidential - HiberCell Inc
In Part A a 3 3 de-escalation design will be used to determine the MTD of CDX-1140 when administered in combination with odetiglucan the starting dose for CDX-1140 is that anticipated to be the recommended phase 2 dose RP2D based on prior Phase 1 clinical assessment Two cohorts of patients will be enrolled ABA and ABA- and proceed independently through the 33 de-escalation assessment up to 30 patients will be enrolled The following 2 treatment cohorts will be evaluated for safety tolerability and preliminary efficacy
ABA Patients with ABA value 20 mcgmL ABA
ABA- Patients with ABA value 20 mcgmL ABA
Both cohorts will initiate at Dose Level 1 and de-escalate to Dose Level -1 based on the respective 21-day DLT period
Dose Level 1 Odetiglucan 4 mgkg IV plus CDX-1140 15 mgkg
Dose Level -1 Odetiglucan 4 mgkg IV plus CDX-1140 072 mgkg Treatment will be administered in 3-week cycles Odetiglucan will be administered weekly on Days 1 8 and 15 of each cycle followed 15-30 minutes later by administration of CDX-1140 15 mgkg or 072 mgkg IV Day 1 of each cycle
Part B if opened will enroll up to 15 patients to receive odetiglucan 4 mgkg plus the CDX-1140 RP2D identified in Part A As in Part A treatment will be administered in 3-week cycles however both odetiglucan and CDX-1140 will be administered on Day 1 of each cycle no odetiglucan administration on Days 8 and 15 as in Part A If the RP2D differs between Cohort 1 and Cohort 2 at the end of Part A the Sponsor in consult with the SMC may select a single RP2D to investigate or investigate both RP2Ds If a larger total enrollment is required the protocol will be amended to support
Product Odetiglucan and CDX-1140 5 ProtocolAmendment No PGG-PAN2111 Amd0010 Confidential - HiberCell Inc
In Part A a 3 3 de-escalation design will be used to determine the MTD of CDX-1140 when administered in combination with odetiglucan the starting dose for CDX-1140 is that anticipated to be the recommended phase 2 dose RP2D based on prior Phase 1 clinical assessment Two cohorts of patients will be enrolled ABA and ABA- and proceed independently through the 33 de-escalation assessment up to 30 patients will be enrolled The following 2 treatment cohorts will be evaluated for safety tolerability and preliminary efficacy
ABA Patients with ABA value 20 mcgmL ABA
ABA- Patients with ABA value 20 mcgmL ABA
Both cohorts will initiate at Dose Level 1 and de-escalate to Dose Level -1 based on the respective 21-day DLT period
Dose Level 1 Odetiglucan 4 mgkg IV plus CDX-1140 15 mgkg
Dose Level -1 Odetiglucan 4 mgkg IV plus CDX-1140 072 mgkg Treatment will be administered in 3-week cycles Odetiglucan will be administered weekly on Days 1 8 and 15 of each cycle followed 15-30 minutes later by administration of CDX-1140 15 mgkg or 072 mgkg IV Day 1 of each cycle
Part B if opened will enroll up to 15 patients to receive odetiglucan 4 mgkg plus the CDX-1140 RP2D identified in Part A As in Part A treatment will be administered in 3-week cycles however both odetiglucan and CDX-1140 will be administered on Day 1 of each cycle no odetiglucan administration on Days 8 and 15 as in Part A If the RP2D differs between Cohort 1 and Cohort 2 at the end of Part A the Sponsor in consult with the SMC may select a single RP2D to investigate or investigate both RP2Ds If a larger total enrollment is required the protocol will be amended to support
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