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ACTIVE NOT RECRUITING
NCT06119217
PHASE2

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

Sponsor: Trishula Therapeutics, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

194

Start Date

2024-03-25

Completion Date

2027-06

Last Updated

2024-12-04

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

TTX-030, nab-paclitaxel and gemcitabine

Dose and schedule per protocol

COMBINATION_PRODUCT

TTX-030, budigalimab, nab-paclitaxel and gemcitabine

Dose and schedule per protocol

COMBINATION_PRODUCT

Nab-Paclitaxel and gemcitabine

Dose and schedule per protocol

Locations (64)

Investigative Site

Tucson, Arizona, United States

Investigative SIte

Hot Springs, Arkansas, United States

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Bakersfield, California, United States

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Fullerton, California, United States

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Los Angeles, California, United States

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Denver, Colorado, United States

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St. Petersburg, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Wichita, Kansas, United States

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Baton Rouge, Louisiana, United States

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Columbia, Maryland, United States

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Burnsville, Minnesota, United States

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Las Vegas, Nevada, United States

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Florham Park, New Jersey, United States

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Asheville, North Carolina, United States

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Columbus, Ohio, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

Investigative Site

Horsham, Pennsylvania, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Arlington, Virginia, United States

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Norfolk, Virginia, United States

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Roanoke, Virginia, United States

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Milwaukee, Wisconsin, United States

Investigative Site

Albury, New South Wales, Australia

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Westmead, New South Wales, Australia

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Herston, Queensland, Australia

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Besançon, France

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Dijon, France

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Lille, France

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Paris, France

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Poitiers, France

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Genova, Italy

Investigative Site

Meldola, Italy

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Milan, Italy

Investigative Site

Pavia, Italy

Investigative Site

Puglia, Italy

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Verona, Italy

Investigative Site

Goyang-si, South Korea

Investigative Site

Seongam, South Korea

Investigative Site

Seongnam-si, South Korea

Investigative Site

Seoul, South Korea

Investigative Site

Seoul, South Korea

Investigative Site

Seoul, South Korea

Investigative Site

Seoul, South Korea

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Seoul, South Korea

Investigative Site

Barcelona, Spain

Investigative Site

Barcelona, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

Investigative Site

Majadahonda, Spain

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Pamplona, Spain

Investigative Site

Valencia, Spain

Investigative Site

Zaragoza, Spain

Investigative Site

Kaohsiung City, Taiwan

Investigative Site

Taichung, Taiwan

Investigative Site

Tainan, Taiwan

Investigative Site

Taipei, Taiwan

Investigative Site

Taoyuan District, Taiwan