RecruitingPhase 2NCT04482309

A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)


Sponsor

AstraZeneca

Enrollment

468 participants

Start Date

Aug 18, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors. This study will consist of Part 1 which includes 7 cohorts of: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors; and Part 2 which includes 5 cohorts A to E of: A) any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer), B) any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer), C) HER2 IHC 2+ or 1+ endometrial cancer, D) HER2 IHC 2+ or 1+ ovarian cancer, and E) HER2 IHC 2+ or 1+ cervical cancer. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study tests an antibody-drug conjugate called T-DXd (trastuzumab deruxtecan) in patients with advanced or metastatic cancers that have high levels of the HER2 protein on tumor cells. It covers multiple cancer types that are not commonly associated with HER2 but may still express it. **You may be eligible if...** - You have locally advanced, unresectable, or metastatic cancer - Your cancer is one of the following types: biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancer, or a rare tumor type that tests positive for HER2 - Your cancer has progressed despite prior treatment - You are 18 or older with adequate organ function **You may NOT be eligible if...** - Your cancer type is breast, gastric, colorectal, or non-small cell lung (these are excluded from certain cohorts) - You have significant lung disease or prior severe drug reactions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab deruxtecan

Trastuzumab deruxtecan by intravenous infusion


Locations(123)

Research Site

Burbank, California, United States

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Duarte, California, United States

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Fullerton, California, United States

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La Jolla, California, United States

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Santa Rosa, California, United States

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Muncie, Indiana, United States

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Montreal, Quebec, Canada

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St Louis, Missouri, United States

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Middletown, New Jersey, United States

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Harrison, New York, United States

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Montreal, Canada

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Kolkata, India

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Detroit, Michigan, United States

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Fairfax, Virginia, United States

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Auchenflower, Australia

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Blacktown, Australia

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Camperdown, Australia

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Heidelberg, Australia

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Nedlands, Australia

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Leuven, Belgium

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Liège, Belgium

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Barretos, Brazil

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Curitiba, Brazil

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Natal, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Ribeirão Preto, Brazil

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Vitória, Brazil

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Kelowna, British Columbia, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Québec, Quebec, Canada

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Brno, Czechia

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Hradec Králové, Czechia

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Olomouc, Czechia

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Ostrava, Czechia

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Prague, Czechia

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Prague, Czechia

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Gurgaon, India

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Madurai, India

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Nashville, Tennessee, United States

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Boston, Massachusetts, United States

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Houston, Texas, United States

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Brussels, Belgium

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Delhi, India

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Ottawa, Ontario, Canada

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Columbus, Ohio, United States

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Rochester, New York, United States

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Los Angeles, California, United States

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Seattle, Washington, United States

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Nashik, India

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Krakow, Poland

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Napoli, Italy

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Roma, Italy

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Chūōku, Japan

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Kashiwa, Japan

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Suita-shi, Japan

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Delft, Netherlands

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Groningen, Netherlands

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Bydgoszcz, Poland

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Gdansk, Poland

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Gliwice, Poland

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Poznan, Poland

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Kaluga, Russia

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Córdoba, Spain

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Moscow, Russia

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Moscow, Russia

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Moscow, Russia

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Glasgow, United Kingdom

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Taichung, Taiwan

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Tainan, Taiwan

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Valencia, Spain

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Rome, Italy

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Amsterdam, Netherlands

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Taoyuan District, Taiwan

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Warsaw, Poland

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Barcelona, Spain

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Hat Yai, Thailand

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Khon Kaen, Thailand

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Muang, Thailand

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Muang, Thailand

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Ongkharak, Thailand

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Si Sa Ket, Thailand

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Madrid, Spain

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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Chiang Mai, Thailand

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Mumbai, India

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Mumbai, India

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Milan, Italy

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Milan, Italy

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Northwood Middlesex, United Kingdom

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Sutton, United Kingdom

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Manchester, United Kingdom

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Moscow, Russia

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Moscow, Russia

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Moscow, Russia

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New York, New York, United States

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New York, New York, United States

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Chicago, Illinois, United States

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Durham, North Carolina, United States

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Melbourne, Australia

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London, United Kingdom

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Brussels, Belgium

Research Site

São Paulo, Brazil

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NCT04482309