Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated to one of three treatment arms.
In Arm 1 (Experimental), participants will receive TTX-030 immunotherapy, plus nab-paclitaxel and gemcitabine chemotherapy.
In Arm 2 (Experimental), participants will receive TTX-030 immunotherapy, plus budigalimab immunotherapy and nab-paclitaxel and gemcitabine chemotherapy.
In Arm 3 (Active Comparator), participants will receive nab-paclitaxel and gemcitabine chemotherapy.
Conditions
This trial is treating people with metastatic pancreatic adenocarcinoma who have not had treatment for their metastatic disease
Eligibility
Inclusion
- Age 18 years or older, is willing and able to provide informed consent
- Histologically or cytologically confirmed diagnosis of metastatic PDAC.
- No prior systemic treatment for metastatic disease.
- Evidence of measurable disease per RECIST 1.1.
- Appropriate for treatment with nab-paclitaxel and gemcitabine chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Exclusion
- History of clinically significant allergy or hypersensitivity to planned study treatment components or to any monoclonal antibody
- Use of investigational agent within 14 days prior to the first dose of study drug
- History of autoimmune disease
- Subject has received live vaccine within 28 days prior to the first dose of study drug
- Has uncontrolled intercurrent illness
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Trishula Therapeutics, Inc.
Scientific 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
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