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Brief Title: 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)

INTRODUCTION

  • Org Study ID: D967VC00001
  • Secondary ID: N/A
  • NTC ID: NCT04482309
  • Sponsor: AstraZeneca

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    August 18, 2020
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Objective Response Rate (ORR)

Primary Outcome 1 - Timeframe: An average of approximately 12 months

CONDITION

  • Bladder Cancer
  • Biliary Tract Cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Rare Tumors

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

LOCATION

Facility Status Contact
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Duarte, California 91010
United States
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Fullerton, California 92835
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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Fairfax, Virginia 22031
United States
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Seattle, Washington 98109
United States
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Auchenflower, Alberta 4066
Australia
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Camperdown, British Columbia 2050
Australia
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Heidelberg, Ontario 3084
Australia
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Nedlands, Quebec 6009
Australia
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Brussels, 1090
Belgium
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Bruxelles, 1200
Belgium
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Leuven, 3000
Belgium
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Liège, 4000
Belgium
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Kelowna, V1Y 5L3
Canada
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Montreal, H2X 0A9
Canada
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Montreal, H3T 1E2
Canada
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Quebec, G1R 2J6
Canada
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Hradec Kralove, 500 05
Czechia
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Olomouc, 775 20
Czechia
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Praha 5, 150 06
Czechia
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Praha 8, 180 81
Czechia
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Gurgaon, 122001
India
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Madurai, 625107
India
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Mumbai, 400012
India
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Rohini, 110 085
India
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Milan, 20162
Italy
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Napoli, 80131
Italy
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Roma, 00128
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, 1066CX
Netherlands
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Delft, 2625 AD
Netherlands
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Groningen, 9700
Netherlands
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Bydgoszcz, 85-796
Poland
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Gdańsk, 80-214
Poland
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Gliwice, 44-101
Poland
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Kraków, 30-688
Poland
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Poznan, 60-780
Poland
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Warszawa, 02-781
Poland
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Kaluga, 248007
Russian Federation
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Moscow, 115478
Russian Federation
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Moscow, 117997
Russian Federation
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Moscow, 121205
Russian Federation
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Moscow, 143423
Russian Federation
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Moscow, 143442
Russian Federation
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Saint Petersburg, 195271
Russian Federation
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Saint-Petersburg, 197758
Russian Federation
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Barcelona, 08908
Spain
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Barcelona, 8035
Spain
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Córdoba, 14004
Spain
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Madrid, 28007
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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Santander, 39008
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, 10300
Thailand
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Bangkok, 10330
Thailand
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Bangkok, 10400
Thailand
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Bangkok, 10700
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, 34000
Thailand
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Muang, 50200
Thailand
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Ongkharak, 26120
Thailand
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Sisaket, 33000
Thailand
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Glasgow, G12 0YN
United Kingdom
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London, SW2 6JJ
United Kingdom
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Northwood Middlesex, HA6 2RN
United Kingdom
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Sutton, SM2 5PT
United Kingdom
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