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

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Abbreviated Inclusion Criteria:

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.

Abbreviated Exclusion Criteria:

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

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