Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06119217
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-09-22
Brief Title:
Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients
Sponsor:
Trishula Therapeutics Inc
Organization:
Trishula Therapeutics Inc
Study Overview
Official Title:
An Open-Label Multicenter 3-Arm Randomized Phase 2 Study to Assess the Efficacy and Safety of TTX-030 and Chemotherapy With or Without Budigalimab Compared to Chemotherapy Alone for the Treatment of Patients Not Previously Treated for Metastatic Pancreatic Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-10
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 2 multicenter open-label 3-arm randomized parallel group study to evaluate the efficacy and safety of TTX-030 with or without budigalimab in combination with chemotherapy gemcitabine nab-paclitaxel in subjects with metastatic PDAC who did not have prior treatment for metastatic disease and are eligible to receive gemcitabine and nab-paclitaxel chemotherapy as SOC
Detailed Description:
None
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