For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Locally advanced, unresectable, or metastatic disease based on most recent imaging.
  2. 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. Progressed following prior treatment or who have no satisfactory alternative treatment option.
  11. Prior HER2 targeting therapy is permitted.
  12. HER2 expression for eligibility may be based on local or central assessment.
  13. Has measurable target disease assessed by the Investigator based on RECIST version 1.1.
  14. Has protocol
  15. defined adequate organ function including cardiac, renal and hepatic function.

EXCLUSION CRITERIA

  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.
  7. Medical conditions that may interfere with the subject's participation in the study.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study’s details


Contition

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

Age

18+

Phase

Phase 2

Participants needed

268

Est. Completion Date

Jun 2023

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT04482309

Study number

D967VC00001

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