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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trishula Therapeutics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 17, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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