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Trial record 1 of 1 for:    TTX-030-003 | Pancreatic Cancer
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Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients

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ClinicalTrials.gov Identifier: NCT06119217
Recruitment Status : Recruiting
First Posted : November 7, 2023
Last Update Posted : March 18, 2024
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Trishula Therapeutics, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Combination Product: TTX-030, nab-paclitaxel and gemcitabine Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine Combination Product: Nab-Paclitaxel and gemcitabine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Parallel Group Study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 2024
Estimated Primary Completion Date : February 2027
Estimated Study Completion Date : June 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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) [ Time Frame: Through study completion, an average of 1 year ]
    ORR is defined as the percentage of subjects who achieve best overall response (BOR) of either complete response (CR) or partial response (PR)

  3. Duration of Response (DoR) [ Time Frame: Through study completion, an average of 1 year ]
    DoR will be defined as the time from the first documentation of disease response (CR or PR) until first documentation of progression or death from any cause, whichever comes first.

  4. Overall Survival (OS) [ Time Frame: Through study completion, an average of 1 year ]
    OS is defined as the time from randomization until death due to any cause.

  5. Adverse Events [ Time Frame: Through study completion, an average of 1 year ]
    Type, severity, and frequency of treatment-emergent AEs


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06119217


Contacts
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Contact: Trishula Therapeutics, Inc. +1 888-480-0554 clinicaltrials@trishulatx.com

Locations
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United States, Arizona
Investigative Site Recruiting
Tucson, Arizona, United States, 85704
United States, Florida
Investigative Site Recruiting
Saint Petersburg, Florida, United States, 33705
Investigative Site Recruiting
Tallahassee, Florida, United States, 32308
Investigative Site Recruiting
West Palm Beach, Florida, United States, 33401
United States, New Jersey
Investigative Site Recruiting
Florham Park, New Jersey, United States, 07932
United States, Ohio
Investigative Site Recruiting
Columbus, Ohio, United States, 43219
United States, Pennsylvania
Investigative Site Recruiting
Horsham, Pennsylvania, United States, 19044
United States, Texas
Investigative Site Recruiting
Dallas, Texas, United States, 75246
Investigative Site Recruiting
San Antonio, Texas, United States, 78258
United States, Virginia
Investigative Site Recruiting
Arlington, Virginia, United States, 22205
Sponsors and Collaborators
Trishula Therapeutics, Inc.
AbbVie
More Information
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Responsible Party: Trishula Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT06119217    
Other Study ID Numbers: TTX-030-003
First Posted: November 7, 2023    Key Record Dates
Last Update Posted: March 18, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Trishula Therapeutics, Inc.:
Cancer
Pancreatic Adenocarcinoma
Immuno-oncology
Pancreatic Ductal Adenocarcinoma
Combination Therapy
CD39
 Adenosine Pathway
Immunotherapy
PD-1 Checkpoint Inhibitor
Budigalimab
TTX-030
metastatic
Additional relevant MeSH terms:
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Paclitaxel
Albumin-Bound Paclitaxel
Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites