NCT06119217

Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients

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: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Trishula Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	TTX-030, nab-paclitaxel and gemcitabine	Dose and schedule per protocol
COMBINATION_PRODUCT	TTX-030, budigalimab, nab-paclitaxel and gemcitabine	Dose and schedule per protocol
COMBINATION_PRODUCT	Nab-Paclitaxel and gemcitabine	Dose and schedule per protocol

Timeline

• Start date: 2024-03-25
• Primary completion: 2027-02-01
• Completion: 2027-06-01
• First posted: 2023-11-07
• Last updated: 2024-12-04

Locations

64 sites across 7 countries: United States, Australia, France, Italy, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study