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BRIEF TITLE: Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)

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)


  • Org Study ID: D967VC00001
  • Secondary ID:
  • NCT ID: NCT04482309
  • NCT Alias:
  • Sponsor: AstraZeneca - Industry
  • Source: 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.

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

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: An average of approximately 12 months

Condition:

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

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:

- Uncontrolled intercurrent illness

- History of non-infectious pneumonitis/ILD, 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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Healthy Volunteers: No

Overall Contact

Name: AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Locations

Facility Status Contact
Research Site
Fullerton, California 92835
United States
Not yet recruiting
Research Site
La Jolla, California 92093
United States
Not yet recruiting
Research Site
Los Angeles, California 90095
United States
Not yet recruiting
Research Site
Santa Rosa, California 95403
United States
Not yet recruiting
Research Site
Chicago, Illinois 60637
United States
Not yet recruiting
Research Site
Muncie, Indiana 47303
United States
Not yet recruiting
Research Site
Boston, Massachusetts 02215
United States
Not yet recruiting
Research Site
Detroit, Michigan 48201
United States
Not yet recruiting
Research Site
Commack, New York 11725
United States
Not yet recruiting
Research Site
New York, New York 10029
United States
Not yet recruiting
Research Site
Rochester, New York 14642
United States
Not yet recruiting
Research Site
Durham, North Carolina 27710
United States
Not yet recruiting
Research Site
Houston, Texas 77030
United States
Recruiting
Research Site
Fairfax, Virginia 22031
United States
Not yet recruiting
Research Site
Seattle, Washington 98109
United States
Not yet recruiting
Research Site
Ribeirão Preto, 14051-140
Brazil
Not yet recruiting
Research Site
London, Ontario N6A 5W9
Canada
Not yet recruiting
Research Site
Olomouc, 775 20
Czechia
Not yet recruiting
Research Site
Milan, 20141
Italy
Not yet recruiting
Research Site
Milan, 20162
Italy
Not yet recruiting
Research Site
Napoli, 80131
Italy
Not yet recruiting
Research Site
Roma, 00128
Italy
Not yet recruiting
Research Site
Rome, 168
Italy
Not yet recruiting
Research Site
Seoul, 03080
Korea, Republic of
Recruiting
Research Site
Seoul, 03722
Korea, Republic of
Recruiting
Research Site
Seoul, 5505
Korea, Republic of
Not yet recruiting
Research Site
Seoul, 6351
Korea, Republic of
Not yet recruiting
Research Site
Gdańsk, 80-214
Poland
Not yet recruiting
Research Site
Gliwice, 44-101
Poland
Not yet recruiting
Research Site
Kraków, 30-688
Poland
Not yet recruiting
Research Site
Poznan, 60-780
Poland
Not yet recruiting
Research Site
Warszawa, 02-781
Poland
Not yet recruiting
Research Site
Kaluga, 248007
Russian Federation
Not yet recruiting
Research Site
Moscow, 117997
Russian Federation
Not yet recruiting
Research Site
Moscow, 143442
Russian Federation
Not yet recruiting
Research Site
Saint-Petersburg, 197758
Russian Federation
Recruiting
Research Site
Tainan, 736
Taiwan
Recruiting
Research Site
Taipei, 100
Taiwan
Recruiting
Research Site
Taipei, 11217
Taiwan
Recruiting
Research Site
Bangkok, 10210
Thailand
Not yet recruiting
Research Site
Bangkok, 10300
Thailand
Not yet recruiting
Research Site
Bangkok, 10330
Thailand
Not yet recruiting
Research Site
Bangkok, 10400
Thailand
Not yet recruiting
Research Site
Chiang Mai, 50200
Thailand
Not yet recruiting
Research Site
Hat Yai, 90110
Thailand
Not yet recruiting
Research Site
Khon Kaen, 40002
Thailand
Not yet recruiting
Research Site
Muang, 50200
Thailand
Not yet recruiting
Research Site
Sisaket, 33000
Thailand
Not yet recruiting