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Pancreatic CancerPhase 2NCT06119217

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

A Phase 2 study testing TTX-030, nab-paclitaxel and gemcitabine, TTX-030, budigalimab, nab-paclitaxel and gemcitabine and Nab-Paclitaxel and gemcitabine in people with Pancreatic Cancer, run by Trishula Therapeutics, Inc. at 64 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
TTX-030, nab-paclitaxel and gemcitabine, TTX-030, budigalimab, nab-paclitaxel and gemcitabine and Nab-Paclitaxel and gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
64 sitesin 7 countries
Study dates
25 Mar 2024to 6 Mar 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

64 sites in 7 countries.

64 sites in 7 countries

United States28 sites

  • Investigative Site

    Arlington, Virginia, 22205

  • Investigative Site

    Asheville, North Carolina, 28806

  • Investigative Site

    Atlanta, Georgia, 30318

  • Investigative Site

    Austin, Texas, 78705

  • Investigative Site

    Bakersfield, California, 93309

  • Investigative Site

    Baton Rouge, Louisiana, 70809

  • Investigative Site

    Burnsville, Minnesota, 55337

  • Investigative Site

    Columbia, Maryland, 21044

  • Investigative Site

    Columbus, Ohio, 43219

  • Investigative Site

    Dallas, Texas, 75246

  • Investigative Site

    Denver, Colorado, 80218

  • Investigative Site

    Eugene, Oregon, 97401

  • Investigative Site

    Florham Park, New Jersey, 07932

  • Investigative Site

    Fullerton, California, 92835

  • Investigative Site

    Horsham, Pennsylvania, 19044

  • Investigative SIte

    Hot Springs, Arkansas, 71913

  • Investigative Site

    Las Vegas, Nevada, 89119

  • Investigative Site

    Los Angeles, California, 90095

  • Investigative Site

    Milwaukee, Wisconsin, 53226

  • Investigative Site

    Norfolk, Virginia, 23502

  • Investigative Site

    Portland, Oregon, 97239

  • Investigative Site

    Roanoke, Virginia, 24014

  • Investigative Site

    San Antonio, Texas, 78258

  • Investigative Site

    St. Petersburg, Florida, 33705

  • Investigative Site

    Tucson, Arizona, 85704

  • Investigative Site

    Tyler, Texas, 75702

  • Investigative Site

    West Palm Beach, Florida, 33401

  • Investigative Site

    Wichita, Kansas, 67214

Other trials in United States

Spain9 sites

  • Investigative Site

    Barcelona, 08009

  • Investigative Site

    Barcelona, 08035

  • Investigative Site

    Madrid, 28040

  • Investigative Site

    Madrid, 28041

  • Investigative Site

    Madrid, 28050

  • Investigative Site

    Majadahonda, 28222

  • Investigative Site

    Pamplona, 31008

  • Investigative Site

    Valencia, 46009

  • Investigative Site

    Zaragoza, 50009

Other trials in Spain

South Korea8 sites

  • Investigative Site

    Goyang-si, 10408

  • Investigative Site

    Seongam, 13496

  • Investigative Site

    Seongnam-si, 13620

  • Investigative Site

    Seoul, 03080

  • Investigative Site

    Seoul, 03722

  • Investigative Site

    Seoul, 05505

  • Investigative Site

    Seoul, 06351

  • Investigative Site

    Seoul, 08308

Other trials in South Korea

Italy6 sites

  • Investigative Site

    Genova, 16132

  • Investigative Site

    Meldola, 47014

  • Investigative Site

    Milan, 20132

  • Investigative Site

    Pavia, 27100

  • Investigative Site

    Puglia, 70124

  • Investigative Site

    Verona, 37134

Other trials in Italy

France5 sites

  • Investigative Site

    Besançon, 25030

  • Investigative Site

    Dijon, 21079

  • Investigative Site

    Lille, 59000

  • Investigative Site

    Paris, 75013

  • Investigative Site

    Poitiers, 86021

Other trials in France

Taiwan5 sites

  • Investigative Site

    Kaohsiung City, 833401

  • Investigative Site

    Taichung, 40447

  • Investigative Site

    Tainan, 70403

  • Investigative Site

    Taipei, 112

  • Investigative Site

    Taoyuan

Other trials in Taiwan

Australia3 sites

  • Investigative Site

    Albury, New South Wales, 2640

  • Investigative Site

    Herston, Queensland, 4029

  • Investigative Site

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: 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.

Being tested
TTX-030, nab-paclitaxel and gemcitabine, TTX-030, budigalimab, nab-paclitaxel and gemcitabine, Nab-Paclitaxel and gemcitabine
Keywords
Cancer, Pancreatic Adenocarcinoma, Combination Therapy, CD39, Adenosine Pathway, Immunotherapy, Immuno-oncology, Pancreatic Ductal Adenocarcinoma, PD-1 Checkpoint Inhibitor, Budigalimab, TTX-030, metastatic
Medical subject headings
Pancreatic Neoplasms, Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TTX-030, nab-paclitaxel and gemcitabineCombination product

    Dose and schedule per protocol

  • TTX-030, budigalimab, nab-paclitaxel and gemcitabineCombination product

    Dose and schedule per protocol

  • Nab-Paclitaxel and gemcitabineCombination product

    Dose and schedule per protocol

Study groups in NCT06119217
Study groupRoleWhat they receive
Arm 1ExperimentalTTX-030 plus nab-paclitaxel and gemcitabine
Receives: Combination Product: TTX-030, nab-paclitaxel and gemcitabine
Arm 2ExperimentalTTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine
Receives: Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Arm 3Active comparatorNab-Paclitaxel and gemcitabine
Receives: Combination Product: Nab-Paclitaxel and gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) - Biomarker Enriched Population

    PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first

    Measured: Through study completion, an average of 1 year

Secondary outcomes (4)

  1. Progression-free Survival (PFS) - Overall Population

    PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first.

    Measured: Through study completion, an average of 1 year

  2. Objective Response Rate (ORR) - Biomarker Enriched Population

    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.

    Measured: Through study completion, an average of 1 year

  3. Overall Survival (OS) - Biomarker Enriched Population

    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.

    Measured: Through study completion

  4. Number of Participants With Treatment Emergent Adverse Events

    Number of treatment emergent adverse events in all participants who received any dose of study treatment.

    Measured: Through study completion, up to a max of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start25 Mar 2024
  3. Primary completion17 Nov 2025
  4. Study completion6 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Parallel Group Study
Masking
None (open label)
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06119217
Sponsor's protocol ID
TTX-030-003
Status last verified
Apr 2026
First submitted
22 Sep 2023
Last updated
13 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TTX-030, nab-paclitaxel and gemcitabine, TTX-030, budigalimab, nab-paclitaxel and gemcitabine and Nab-Paclitaxel and gemcitabine in people with Pancreatic Cancer, run by Trishula Therapeutics, Inc. at 64 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Spain, South Korea, Italy, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) - Biomarker Enriched Population (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06119217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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