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

Phase 2Active Not RecruitingNCT06119217

Trishula Therapeutics, Inc.194 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

194

Conditions

Pancreatic Cancer

Interventions

TTX-030, nab-paclitaxel and gemcitabineCOMBINATION_PRODUCT

Dose and schedule per protocol

TTX-030, budigalimab, nab-paclitaxel and gemcitabineCOMBINATION_PRODUCT

Dose and schedule per protocol

Nab-Paclitaxel and gemcitabineCOMBINATION_PRODUCT

Dose and schedule per protocol

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (64)

Outcomes

Primary Outcomes

Progression-free survival (PFS) - Biomarker Enriched Population

PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first