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ACTIVE NOT RECRUITING
NCT04482309
PHASE2

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

477

Start Date

2020-08-18

Completion Date

2027-03-23

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

Trastuzumab deruxtecan

Trastuzumab deruxtecan by intravenous infusion

Locations (89)

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Duarte, California, United States

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Santa Rosa, California, United States

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Chicago, Illinois, United States

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Muncie, Indiana, United States

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Boston, Massachusetts, United States

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Middletown, New Jersey, United States

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Harrison, New York, United States

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New York, New York, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Houston, Texas, United States

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Seattle, Washington, 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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Melbourne, Australia

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Nedlands, Australia

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Brussels, Belgium

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Leuven, Belgium

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Liège, Belgium

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Porto Alegre, Brazil

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São Paulo, Brazil

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Vitória, Brazil

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Kelowna, British Columbia, Canada

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Ottawa, Ontario, Canada

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Québec, Quebec, Canada

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Montreal, Canada

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Brno, Czechia

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Hradec Králové, Czechia

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Olomouc, Czechia

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Prague, Czechia

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Prague, Czechia

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Delhi, India

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Gūrgaon, India

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Kolkata, India

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Mumbai, India

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Milan, Italy

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Milan, Italy

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Naples, Italy

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Rome, Italy

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Chūōku, Japan

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Kashiwa, Japan

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Suita-shi, Japan

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Amsterdam, Netherlands

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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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Krakow, Poland

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Poznan, Poland

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Warsaw, Poland

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Kaluga, Russia

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Moscow, Russia

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Moscow, Russia

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Moscow, Russia

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Moscow, Russia

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Moscow, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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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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Barcelona, Spain

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Córdoba, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Valencia, Spain

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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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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Hat Yai, Thailand

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Khon Kaen, Thailand

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Muang, Thailand

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Ongkharak, Thailand

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London, United Kingdom

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Manchester, United Kingdom

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Sutton, United Kingdom