Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06182072
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-11-21
Brief Title:
ProAgio in Pancreatic Ductal Adenocarcinoma PDAC
Sponsor:
ProDa BioTech LLC
Organization:
ProDa BioTech LLC
Study Overview
Official Title:
A Phase IIb Trial of ProAgio an Anti- αvβ3 Integrin Cytotoxin in Combination With Gemcitabine and Nab-paclitaxel for Advanced Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
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 an open-label Phase IIb dose-escalation dose-expansion clinical trial of the safety pharmacokinetics and clinical activity of ProAgio combined with gemcitabine and nab paclitaxel G-nP in previously untreated subjects with metastatic pancreatic ductal adenocarcinoma PDAC
Detailed Description:
This is an open-label Phase IIb dose-escalation dose-expansion clinical trial of the safety pharmacokinetics and clinical activity of ProAgio combined with gemcitabine and nab paclitaxel G-nP in previously untreated subjects with metastatic PDAC The study will use an EWOC design in Phase I to determine the recommended RP2D of ProAgio with gemcitabine and nab paclitaxel G-nP After the estimation of RP2D of ProAgio alone the trial will continue to estimate the RP2D of ProAgio when combined with G-nP starting from 2 dose levels lower than the estimated RP2D of ProAgio alone EWOC design will enroll 2 subjects per cohort with 4 combination dose levels
Subjects will be selected based on following criteria previously untreated advanced PDAC ECOG performance status 0-1 and adequate organ functions Subjects with recent surgeries history of recent thromboembolic events or significant cardiovascular disease will be excluded
Once the MTD and RP2D of ProAgio with G-nP RP2D have been identified an expansion cohort of 12 subjects with metastatic PDAC n6 receiving ProAgio and n6 receiving ProAgio GnP will begin The purpose of the expansion cohort is to confirm the safety of the regimen and provide preliminary data on the activity of both ProAgio monotherapy and ProAgio GnP
Data regarding adverse events will be collected attributed and graded according to NCICTCAE criteria Pharmacokinetic and pharmacodynamic data will be collected per the study flow chart Response will be evaluated every 2 months using RECIST criteria Planned secondary analyses will include ORR duration of response PFS and OS
Subjects will be selected based on following criteria previously untreated advanced PDAC ECOG performance status 0-1 and adequate organ functions Subjects with recent surgeries history of recent thromboembolic events or significant cardiovascular disease will be excluded
Once the MTD and RP2D of ProAgio with G-nP RP2D have been identified an expansion cohort of 12 subjects with metastatic PDAC n6 receiving ProAgio and n6 receiving ProAgio GnP will begin The purpose of the expansion cohort is to confirm the safety of the regimen and provide preliminary data on the activity of both ProAgio monotherapy and ProAgio GnP
Data regarding adverse events will be collected attributed and graded according to NCICTCAE criteria Pharmacokinetic and pharmacodynamic data will be collected per the study flow chart Response will be evaluated every 2 months using RECIST criteria Planned secondary analyses will include ORR duration of response PFS and OS
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