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

NCT06119217 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2026-05-13

Study results available
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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.

Conditions

Interventions

COMBINATION_PRODUCT

TTX-030, nab-paclitaxel and gemcitabine

Dose and schedule per protocol

COMBINATION_PRODUCT

TTX-030, budigalimab, nab-paclitaxel and gemcitabine

Dose and schedule per protocol

COMBINATION_PRODUCT

Nab-Paclitaxel and gemcitabine

Dose and schedule per protocol

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Trishula Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2025-11-17
Completion
2026-03-06
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Italy
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06119217 on ClinicalTrials.gov