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

April 21, 2026 updated by: Trishula Therapeutics, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Investigative Site
      • Westmead, New South Wales, Australia, 2145
        • Investigative Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Investigative Site
  • France
      • Besançon, France, 25030
        • Investigative Site
      • Dijon, France, 21079
        • Investigative Site
      • Lille, France, 59000
        • Investigative Site
      • Paris, France, 75013
        • Investigative Site
      • Poitiers, France, 86021
        • Investigative Site
  • Italy
      • Genova, Italy, 16132
        • Investigative Site
      • Meldola, Italy, 47014
        • Investigative Site
      • Milan, Italy, 20132
        • Investigative Site
      • Pavia, Italy, 27100
        • Investigative Site
      • Puglia, Italy, 70124
        • Investigative Site
      • Verona, Italy, 37134
        • Investigative Site
  • South Korea
      • Goyang-si, South Korea, 10408
        • Investigative Site
      • Seongam, South Korea, 13496
        • Investigative Site
      • Seongnam-si, South Korea, 13620
        • Investigative Site
      • Seoul, South Korea, 03080
        • Investigative Site
      • Seoul, South Korea, 05505
        • Investigative Site
      • Seoul, South Korea, 03722
        • Investigative Site
      • Seoul, South Korea, 06351
        • Investigative Site
      • Seoul, South Korea, 08308
        • Investigative Site
  • Spain
      • Barcelona, Spain, 08009
        • Investigative Site
      • Barcelona, Spain, 08035
        • Investigative Site
      • Madrid, Spain, 28040
        • Investigative Site
      • Madrid, Spain, 28041
        • Investigative Site
      • Madrid, Spain, 28050
        • Investigative Site
      • Majadahonda, Spain, 28222
        • Investigative Site
      • Pamplona, Spain, 31008
        • Investigative Site
      • Valencia, Spain, 46009
        • Investigative Site
      • Zaragoza, Spain, 50009
        • Investigative Site
  • Taiwan
      • Kaohsiung City, Taiwan, 833401
        • Investigative Site
      • Taichung, Taiwan, 40447
        • Investigative Site
      • Tainan, Taiwan, 70403
        • Investigative Site
      • Taipei, Taiwan, 112
        • Investigative Site
      • Taoyuan, Taiwan
        • Investigative Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Investigative Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Investigative Site
    • California
      • Bakersfield, California, United States, 93309
        • Investigative Site
      • Fullerton, California, United States, 92835
        • Investigative Site
      • Los Angeles, California, United States, 90095
        • Investigative Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Investigative Site
    • Florida
      • St. Petersburg, Florida, United States, 33705
        • Investigative Site
      • West Palm Beach, Florida, United States, 33401
        • Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Investigative Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Investigative Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Investigative Site
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Investigative Site
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Investigative Site
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Investigative Site
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Investigative Site
    • Ohio
      • Columbus, Ohio, United States, 43219
        • Investigative Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Investigative Site
      • Portland, Oregon, United States, 97239
        • Investigative Site
    • Pennsylvania
      • Horsham, Pennsylvania, United States, 19044
        • Investigative Site
    • Texas
      • Austin, Texas, United States, 78705
        • Investigative Site
      • Dallas, Texas, United States, 75246
        • Investigative Site
      • San Antonio, Texas, United States, 78258
        • Investigative Site
      • Tyler, Texas, United States, 75702
        • Investigative Site
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Investigative Site
      • Norfolk, Virginia, United States, 23502
        • Investigative Site
      • Roanoke, Virginia, United States, 24014
        • Investigative Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
TTX-030 plus nab-paclitaxel and gemcitabine
Combination product: TTX-030, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
Experimental: Arm 2
TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine
Combination product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
Active Comparator: Arm 3
Nab-Paclitaxel and gemcitabine
Combination product: Nab-Paclitaxel and gemcitabine
Dose and schedule per protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) - Biomarker Enriched Population
Time Frame: Through study completion, an average of 1 year
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) - Overall Population
Time Frame: Through study completion, an average of 1 year
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first.
Through study completion, an average of 1 year
Objective Response Rate (ORR) - Biomarker Enriched Population
Time Frame: Through study completion, an average of 1 year
Objective response rate (ORR) is defined as the proportion of subjects who achieve best overall response (BOR) of either complete response (CR) or partial response (PR) as assessed by the investigators per RECIST v1.1. The BOR is the best response (in the order of CR, PR, stable disease [SD], and progressive disease [PD]) documented from the date of randomization until the end of study, first disease progression, death, or start of new anti-cancer therapy, or last documented assessment before ≥2 consecutive missing tumor assessments, whichever is earlier.
Through study completion, an average of 1 year
Overall Survival (OS) - Biomarker Enriched Population
Time Frame: Through study completion
OS is defined as the time from randomization until death due to any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Outcome measure is the Kaplan-Meier estimate of OS rate at 12 months.
Through study completion
Number of Participants With Treatment Emergent Adverse Events
Time Frame: Through study completion, up to a max of 2 years
Number of treatment emergent adverse events in all participants who received any dose of study treatment.
Through study completion, up to a max of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trishula Therapeutics, Inc.

Collaborators

AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2024

Primary Completion (Actual)

November 17, 2025

Study Completion (Actual)

March 6, 2026

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTX-030-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on TTX-030, budigalimab, nab-paclitaxel and gemcitabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe