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

NCT06119217 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TTX-030-003
• Study Type: interventional
• Target: 194
• Locations: 7 countries
• Sites: 64

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.

Conditions

Pancreatic Cancer

Keywords

Cancer; Pancreatic Adenocarcinoma; Combination Therapy; CD39; Adenosine Pathway; Immunotherapy; Immuno-oncology; Pancreatic Ductal Adenocarcinoma; PD-1 Checkpoint Inhibitor; Budigalimab; TTX-030; metastatic

Outcome Measures

Primary Outcomes (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

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• Progression-free survival (PFS) - Overall Population

  Through study completion, an average of 1 year

• Objective Response Rate (ORR)

  Through study completion, an average of 1 year

• Duration of Response (DoR)

  Through study completion, an average of 1 year

• Overall Survival (OS)

  Through study completion, an average of 1 year

• Adverse Events

  Through study completion, an average of 1 year

Study Arms (3)

Arm 1

EXPERIMENTAL

TTX-030 plus nab-paclitaxel and gemcitabine

Combination Product: TTX-030, nab-paclitaxel and gemcitabine

Arm 2

EXPERIMENTAL

TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine

Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine

Arm 3

ACTIVE COMPARATOR

Nab-Paclitaxel and gemcitabine

Combination Product: Nab-Paclitaxel and gemcitabine

Interventions

TTX-030, nab-paclitaxel and gemcitabine COMBINATION_PRODUCT

Dose and schedule per protocol

Arm 1

TTX-030, budigalimab, nab-paclitaxel and gemcitabine COMBINATION_PRODUCT

Dose and schedule per protocol

Arm 2

Nab-Paclitaxel and gemcitabine COMBINATION_PRODUCT

Dose and schedule per protocol

Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Trishula Therapeutics, Inc.: lead
• AbbVie: collaborator

Study Sites (64)

Investigative Site

Tucson, Arizona, 85704, United States

Location

Investigative SIte

Hot Springs, Arkansas, 71913, United States

Location

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Bakersfield, California, 93309, United States

Location

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Fullerton, California, 92835, United States

Location

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Los Angeles, California, 90095, United States

Location

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Denver, Colorado, 80218, United States

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St. Petersburg, Florida, 33705, United States

Location

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West Palm Beach, Florida, 33401, United States

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Atlanta, Georgia, 30318, United States

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Wichita, Kansas, 67214, United States

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Baton Rouge, Louisiana, 70809, United States

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Columbia, Maryland, 21044, United States

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Burnsville, Minnesota, 55337, United States

Location

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Las Vegas, Nevada, 89119, United States

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Florham Park, New Jersey, 07932, United States

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Asheville, North Carolina, 28806, United States

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Columbus, Ohio, 43219, United States

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Eugene, Oregon, 97401, United States

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Portland, Oregon, 97239, United States

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Horsham, Pennsylvania, 19044, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75246, United States

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San Antonio, Texas, 78258, United States

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Tyler, Texas, 75702, United States

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Arlington, Virginia, 22205, United States

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Norfolk, Virginia, 23502, United States

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Roanoke, Virginia, 24014, United States

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Milwaukee, Wisconsin, 53226, United States

Location

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Albury, New South Wales, 2640, Australia

Location

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Westmead, New South Wales, 2145, Australia

Location

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Herston, Queensland, 4029, Australia

Location

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Besançon, 25030, France

Location

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Dijon, 21079, France

Location

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Lille, 59000, France

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Paris, 75013, France

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Poitiers, 86021, France

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Genova, 16132, Italy

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Meldola, 47014, Italy

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Milan, 20132, Italy

Location

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Pavia, 27100, Italy

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Puglia, 70124, Italy

Location

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Verona, 37134, Italy

Location

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Goyang-si, 10408, South Korea

Location

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Seongam, 13496, South Korea

Location

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Seongnam-si, 13620, South Korea

Location

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Seoul, 03080, South Korea

Location

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Seoul, 03722, South Korea

Location

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Seoul, 05505, South Korea

Location

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Seoul, 06351, South Korea

Location

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Seoul, 08308, South Korea

Location

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Barcelona, 08009, Spain

Location

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Barcelona, 08035, Spain

Location

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Madrid, 28040, Spain

Location

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Madrid, 28041, Spain

Location

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Madrid, 28050, Spain

Location

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Majadahonda, 28222, Spain

Location

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Pamplona, 31008, Spain

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Valencia, 46009, Spain

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Zaragoza, 50009, Spain

Location

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Kaohsiung City, 833401, Taiwan

Location

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Taichung, 40447, Taiwan

Location

Investigative Site

Tainan, 70403, Taiwan

Location

Investigative Site

Taipei, 112, Taiwan

Location

Investigative Site

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms; Neoplasm Metastasis

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine; budigalimab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Parallel Group Study

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: November 7, 2023
• Study Start: March 25, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); KR (8); US (28); FR (5); IT (6); TW (5); ES (9)