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

Trishula Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Pancreatic Cancer

Treatments: Combination Product: TTX-030, nab-paclitaxel and gemcitabine; Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine; Combination Product: Nab-Paclitaxel and gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06119217

TTX-030-003

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 3 patient groups

Arm 1

Experimental group

Description:

TTX-030 plus nab-paclitaxel and gemcitabine

Treatment:

Combination Product: TTX-030, nab-paclitaxel and gemcitabine

Arm 2

Experimental group

Description:

TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine

Treatment:

Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine

Arm 3

Active Comparator group

Description:

Nab-Paclitaxel and gemcitabine

Treatment:

Combination Product: Nab-Paclitaxel and gemcitabine