Ovarian Cancer Clinical Trial
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
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 enroll 7 tumor-specific cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.
Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.
Locally advanced, unresectable, or metastatic disease based on most recent imaging.
The respective cohorts for patient inclusion are:
Cohort 1: Biliary tract cancer
Cohort 2: Bladder cancer
Cohort 3: Cervical cancer
Cohort 4: Endometrial cancer
Cohort 5: Epithelial ovarian cancer
Cohort 6: Pancreatic cancer
Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.
Progressed following prior treatment or who have no satisfactory alternative treatment option.
Prior HER2 targeting therapy is permitted.
HER2 expression for eligibility may be based on local or central assessment.
Has measurable target disease assessed by the Investigator based on RECIST version 1.1.
Has protocol- defined adequate organ function including cardiac, renal and hepatic function.
History of non-infectious pneumonitis/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening
Lung-specific intercurrent clinically significant severe illnesses
Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART
Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.
Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer.
Medical conditions that may interfere with the subject's participation in the study.
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There are 77 Locations for this study
Duarte California, 91010, United States
Santa Rosa California, 95403, United States
Chicago Illinois, 60637, United States
Muncie Indiana, 47303, United States
Boston Massachusetts, 02215, United States
Middletown New Jersey, 07748, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10029, United States
Durham North Carolina, 27710, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Auchenflower , 4066, Australia
Camperdown , 2050, Australia
Heidelberg , 3084, Australia
Nedlands , 6009, Australia
Brussels , 1090, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Montreal , H3T 1, Canada
Quebec , G1J 1, Canada
Brno , 656 5, Czechia
Hradec Kralove , 500 0, Czechia
Olomouc , 775 2, Czechia
Praha 5 , 150 0, Czechia
Praha 8 , 180 8, Czechia
Delhi , 11008, India
Gurgaon , 12200, India
Kolkata , 70016, India
Mumbai , 40001, India
Milan , 20141, Italy
Milan , 20162, Italy
Roma , 00128, Italy
Rome , 168, Italy
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 5505, Korea, Republic of
Seoul , 6351, Korea, Republic of
Amsterdam , 1066C, Netherlands
Delft , 2625 , Netherlands
Groningen , 9700, Netherlands
Bydgoszcz , 85-79, Poland
Gdańsk , 80-21, Poland
Kraków , 30-68, Poland
Poznan , 60-78, Poland
Warszawa , 02-78, Poland
Kaluga , 24800, Russian Federation
Moscow , 11541, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 11799, Russian Federation
Moscow , 12120, Russian Federation
Moscow , 14342, Russian Federation
Moscow , 14344, Russian Federation
Saint Petersburg , 19527, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Barcelona , 8035, Spain
Córdoba , 14004, Spain
Madrid , 28027, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Valencia , 46014, Spain
Taichung , 40705, Taiwan
Tainan , 736, Taiwan
Taipei , 100, Taiwan
Taipei , 11217, Taiwan
Tao-Yuan , 333, Taiwan
Bangkok , 10210, Thailand
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Chiang Mai , 50200, Thailand
Hat Yai , 90110, Thailand
Khon Kaen , 40002, Thailand
Muang , 50200, Thailand
Ongkharak , 26120, Thailand
London , SW2 6, United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
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