RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 consist of Part 1 which includes 7 cohorts of: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors; and Part 2 which includes 5 cohorts A to E of: A) any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer), B) any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer), C) HER2 IHC 2+ or 1+ endometrial cancer, D) HER2 IHC 2+ or 1+ ovarian cancer, and E) HER2 IHC 2+ or 1+ cervical cancer. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.

Official Title

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)

Quick Facts

Study Start:2020-08-18
Study Completion:2027-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04482309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Locally advanced, unresectable, or metastatic disease based on most recent imaging.
  2. * Part 1:The respective cohorts for patient inclusion are:
  3. * Cohort 1: Biliary tract cancer
  4. * Cohort 2: Bladder cancer
  5. * Cohort 3: Cervical cancer
  6. * Cohort 4: Endometrial cancer
  7. * Cohort 5: Epithelial ovarian cancer
  8. * Cohort 6: Pancreatic cancer
  9. * 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.
  10. * Part 2:The respective cohorts for patient inclusion are:
  11. * Cohort A: Metastatic or advanced solid tumors that are HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer). Patients with non-small cell lung cancer can be included.
  12. * Cohort B: Metastatic or advanced solid tumors that are HER2 IHC 2+/ISH+ any tumor type (excluding breast, gastric cancer, and colorectal cancer). Patients with non-small cell lung cancer can be included.
  13. * Cohort C: Metastatic or advanced solid endometrial cancer that is HER2 IHC 2+ or 1+.
  14. * Cohort D: Metastatic or advanced ovarian cancer that is HER2 IHC 2+ or 1+.
  15. * Cohort E: Metastatic or advanced solid cervical cancer that is HER2 IHC 2+ or 1+.
  16. * Progressed following prior treatment or who have no satisfactory alternative treatment option.
  17. * Prior HER2 targeting therapy is permitted.
  18. * HER2 expression scored using current ASCO/CAP guidelines for scoring HER2 for gastric cancer.
  19. * Part 1: IHC 3+ or IHC 2+ by local or central assessment
  20. * Part 2: IHC and ISH results by central assessment as pre-defined for each cohort
  21. * Has measurable target disease assessed by the Investigator based on RECIST version 1.1.
  22. * Has protocol- defined adequate organ function including cardiac, renal and hepatic function.
  1. * History of non-infectious pneumonitis/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening
  2. * Lung-specific intercurrent clinically significant severe illnesses
  3. * Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
  4. * Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART
  5. * Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.
  6. * 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 for Part 1. For Part 2, patients with primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction will be excluded.
  7. * Medical conditions that may interfere with the subject's participation in the study.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Burbank, California, 91505
United States
Research Site
Duarte, California, 91010
United States
Research Site
Fullerton, California, 92835
United States
Research Site
La Jolla, California, 92093
United States
Research Site
Los Angeles, California, 90095
United States
Research Site
Santa Rosa, California, 95403
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Muncie, Indiana, 47303
United States
Research Site
Boston, Massachusetts, 02215
United States
Research Site
Detroit, Michigan, 48201
United States
Research Site
Saint Louis, Missouri, 63110
United States
Research Site
Middletown, New Jersey, 07748
United States
Research Site
Harrison, New York, 10604
United States
Research Site
New York, New York, 10029
United States
Research Site
New York, New York, 10065
United States
Research Site
Rochester, New York, 14642
United States
Research Site
Durham, North Carolina, 27710
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Fairfax, Virginia, 22031
United States
Research Site
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-18
Study Completion Date2027-07-30

Study Record Updates

Study Start Date2020-08-18
Study Completion Date2027-07-30

Terms related to this study

Keywords Provided by Researchers

  • T-DXd, DS-8201a, Trastuzumab Deruxtecan, HER2

Additional Relevant MeSH Terms

  • Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer
  • Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer