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Completed

NCT Number: NCT06119217

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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site, Albury, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TTX-030, nab-paclitaxel and gemcitabine

Combination Product

Dose and schedule per protocol

TTX-030, budigalimab, nab-paclitaxel and gemcitabine

Combination Product

Dose and schedule per protocol

Nab-Paclitaxel and gemcitabine

Combination Product

Dose and schedule per protocol

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Trishula Therapeutics, Inc.

Industry

Collaborators

  • AbbVie

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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