Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
Start Date
9/6/2022
Completion Date
10/1/2027
Summary
TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.
Detailed Description
This Phase II, open-label, uncontrolled, multicentre study evaluating the efficacy and safety of Dato-DXd as monotherapy (MONO) and in combination with anticancer agents (COMBO) in various advanced solid tumour types. This study has a modular design, as such a master protocol with independent substudies enables simultaneous evaluation of the safety profile, recommended Phase II dose (RP2D), and efficacy of Dato-DXd in multiple disease populations and treatment combinations. This study will evaluate various solid tumour types, including endometrial cancer (Substudy 1), gastric cancer (Substudy 2), metastatic castration-resistant prostate cancer (mCRPC) (Substudy 3), ovarian cancer (Substudy 4), colorectal cancer (CRC) (Substudy 5), urothelial cancer (Substudy 6), and biliary tract cancer (Substudy 7) in the advanced or metastatic setting. Within each substudy, Dato-DXd will be evaluated as monotherapy (for all substudies except Substudy 2) and in combination with approved or novel anticancer agents that may be active in the tumour type being evaluated (for all substudies except Substudy 1 and Substudy 7).
Eligibility Criteria
Age Range: 18 years to 130 years
Interventions
Datopotamab deruxtecan (Dato-DXd)
Capecitabine
5-Fluorouracil
Volrustomig
Carboplatin
Bevacizumab
Rilvegostomig
Prednisone/ prednisolone
Cisplatin
Conditions
Locations
Research Site
Los Angeles, California 90095
United States
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San Diego, California 92103
United States
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Santa Rosa, California 95403
United States
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Muncie, Indiana 47303
United States
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Kansas City, Kansas 66160
United States
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Boston, Massachusetts 02114
United States
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Boston, Massachusetts 02215
United States
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Grand Rapids, Michigan 49503
United States
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East Brunswick, New Jersey 08816
United States
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Albuquerque, New Mexico 87109
United States
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Commack, New York 11725
United States
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Cincinnati, Ohio 45219
United States
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Columbus, Ohio 43219
United States
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Portland, Oregon 97239
United States
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Nashville, Tennessee 37203
United States
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Nashville, Tennessee 37232
United States
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Houston, Texas 77030
United States
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Madison, Wisconsin 53792
United States
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Toronto, Ontario M4N 3M5
Canada
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Toronto, Ontario M5G 2M9
Canada
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Montreal, Quebec H2X 0A9
Canada
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Montreal, Quebec H4A 3J1
Canada
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Québec, Quebec G1J 1Z4
Canada
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Changsha, 410013
China
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Chongqing, 400030
China
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Guangzhou, 510060
China
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Guangzhou, 510060
China
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Guangzhou, 510120
China
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Hangzhou, 310020
China
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Hefei, 230001
China
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Shanghai, 200032
China
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Shanghai, 200032
China
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Shenyang, 110016
China
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Wuhan, 430030
China
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Wuhan, 430079
China
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Xi'an, 710000
China
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Zhengzhou, 450052
China
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Bordeaux, 33076
France
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Lyon, 69373
France
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Marseille, 13273
France
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Suresnes, 92150
France
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Berlin, 10117
Germany
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Essen, 45136
Germany
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Hanover, 30625
Germany
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München, 81377
Germany
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Regensburg, 93053
Germany
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Florence, 50139
Italy
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Genova, 16132
Italy
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Milan, 20132
Italy
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Milan, 20141
Italy
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Milan, 20162
Italy
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Naples, 80131
Italy
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Rome, 00168
Italy
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Chūōku, 104-0045
Japan
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Kashiwa, 277-8577
Japan
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Kōtoku, 135-8550
Japan
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Nagoya, 464-8681
Japan
Research Site
Shinagawa-ku, 142-8666
Japan
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Suita-shi, 565-0871
Japan
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Gliwice, 44-102
Poland
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Krakow, 31-501
Poland
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Lodz, 92-213
Poland
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Poznan, 61-866
Poland
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Warsaw, 02-781
Poland
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Seoul, 03722
South Korea
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Seoul, 05505
South Korea
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Seoul, 06351
South Korea
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Seoul, 110-744
South Korea
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Barcelona, 8035
Spain
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Córdoba, 14004
Spain
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Madrid, 28046
Spain
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Málaga, 29010
Spain
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Pamplona, 31008
Spain
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Seville, 41013
Spain
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Basel, 4031
Switzerland
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Bellinzona, 6500
Switzerland
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Sankt Gallen, 9007
Switzerland
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Liou Ying Township, 736
Taiwan
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Taipei, 100
Taiwan
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Taipei, 11259
Taiwan
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Taipei, 112
Taiwan
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Taoyuan, 333
Taiwan
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Ankara, 06620
Turkey (Türkiye)
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Ankara, 06800
Turkey (Türkiye)
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Cordaleo, 35575
Turkey (Türkiye)
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Edirne, 22030
Turkey (Türkiye)
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Kadıkoy/Istanbul, 34722
Turkey (Türkiye)
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Konya, 42080
Turkey (Türkiye)
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Pamukkale, 20070
Turkey (Türkiye)
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Samsun, 55139
Turkey (Türkiye)
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Cambridge, CB2 0QQ
United Kingdom
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Dundee, DD1 9SY
United Kingdom
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London, EC1A 7BE
United Kingdom
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London, NW1 2PG
United Kingdom
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London, SE1 9RT
United Kingdom
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Manchester, M20 4BX
United Kingdom