Ovarian Cancer Clinical Trial

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

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 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

268

Study ID:

NCT04482309

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 76 Locations for this study

See Locations Near You

Research Site
Duarte California, 91010, United States
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Santa Rosa California, 95403, United States
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Chicago Illinois, 60637, United States
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Muncie Indiana, 47303, United States
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Boston Massachusetts, 02215, United States
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Middletown New Jersey, 07748, United States
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Commack New York, 11725, United States
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Harrison New York, 10604, United States
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New York New York, 10029, United States
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Durham North Carolina, 27710, United States
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Houston Texas, 77030, United States
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Seattle Washington, 98109, United States
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Auchenflower , 4066, Australia
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Camperdown , 2050, Australia
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Heidelberg , 3084, Australia
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Nedlands , 6009, Australia
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Brussels , 1090, Belgium
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Leuven , 3000, Belgium
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Liège , 4000, Belgium
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Montreal , H3T 1, Canada
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Quebec , G1J 1, Canada
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Brno , 656 5, Czechia
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Hradec Kralove , 500 0, Czechia
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Olomouc , 775 2, Czechia
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Praha 5 , 150 0, Czechia
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Praha 8 , 180 8, Czechia
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Delhi , 11008, India
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Gurgaon , 12200, India
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Kolkata , 70016, India
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Mumbai , 40001, India
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Milan , 20141, Italy
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Milan , 20162, Italy
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Rome , 168, Italy
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 5505, Korea, Republic of
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Seoul , 6351, Korea, Republic of
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Amsterdam , 1066C, Netherlands
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Delft , 2625 , Netherlands
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Groningen , 9700, Netherlands
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Bydgoszcz , 85-79, Poland
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Gdańsk , 80-21, Poland
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Kraków , 30-68, Poland
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Poznan , 60-78, Poland
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Warszawa , 02-78, Poland
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Kaluga , 24800, Russian Federation
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Moscow , 11541, Russian Federation
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Moscow , 11547, Russian Federation
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Moscow , 11799, Russian Federation
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Moscow , 12120, Russian Federation
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Moscow , 14342, Russian Federation
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Moscow , 14344, Russian Federation
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Saint Petersburg , 19527, Russian Federation
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Saint-Petersburg , 19775, Russian Federation
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Barcelona , 8035, Spain
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Córdoba , 14004, Spain
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Madrid , 28027, Spain
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Madrid , 28040, Spain
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Madrid , 28041, Spain
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Madrid , 28046, Spain
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Valencia , 46014, Spain
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Taichung , 40705, Taiwan
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Tainan , 736, Taiwan
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Taipei , 100, Taiwan
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Taipei , 11217, Taiwan
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Tao-Yuan , 333, Taiwan
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Bangkok , 10210, Thailand
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Bangkok , 10330, Thailand
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Bangkok , 10400, Thailand
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Chiang Mai , 50200, Thailand
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Hat Yai , 90110, Thailand
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Khon Kaen , 40002, Thailand
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Muang , 50200, Thailand
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Ongkharak , 26120, Thailand
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London , SW2 6, United Kingdom
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Manchester , M20 4, United Kingdom
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Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

268

Study ID:

NCT04482309

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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