Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

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

Keywords

Pancreatic Cancer, Cancer, Pancreatic Adenocarcinoma, Combination Therapy, CD39, Adenosine Pathway, Immunotherapy, Immuno-oncology, Pancreatic Ductal Adenocarcinoma, PD-1 Checkpoint Inhibitor, Budigalimab, TTX-030, metastatic, Paclitaxel, Albumin-Bound Paclitaxel, Gemcitabine, TTX-030, nab-paclitaxel and gemcitabine, TTX-030, budigalimab, nab-paclitaxel and gemcitabine, Nab-Paclitaxel and gemcitabine

Eligibility

For people ages 18 years and up

Abbreviated Inclusion Criteria:

  1. Age 18 years or older, is willing and able to provide informed consent
  2. Histologically or cytologically confirmed diagnosis of metastatic PDAC.
  3. No prior systemic treatment for metastatic disease.
  4. Evidence of measurable disease per RECIST 1.1.
  5. Appropriate for treatment with nab-paclitaxel and gemcitabine chemotherapy.
  6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Abbreviated Exclusion Criteria:

  1. History of clinically significant allergy or hypersensitivity to planned study treatment components or to any monoclonal antibody
  2. Use of investigational agent within 14 days prior to the first dose of study drug
  3. History of autoimmune disease
  4. Subject has received live vaccine within 28 days prior to the first dose of study drug
  5. Has uncontrolled intercurrent illness

Locations

  • Investigative Site accepting new patients
    Los Angeles California 90095 United States
  • Investigative Site accepting new patients
    Fullerton California 92835 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Trishula Therapeutics, Inc.
Links
Sign up for this study
ID
NCT06119217
Phase
Phase 2 Pancreatic Cancer Research Study
Study Type
Interventional
Participants
Expecting 180 study participants
Last Updated