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)

AstraZeneca90 sites in 12 countries477 target enrollmentAugust 18, 2020

ConditionsPart 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

InterventionsTrastuzumab deruxtecan

DrugsTrastuzumab deruxtecan

Overview

Phase: Phase 2
Intervention: Trastuzumab deruxtecan
Conditions: Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer
Sponsor: AstraZeneca
Enrollment: 477
Locations: 90
Primary Endpoint: Objective Response Rate (ORR)
Status: Active, Not Recruiting
Last Updated: 23 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

August 18, 2020

End Date

March 23, 2027

Last Updated

23 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Locally advanced, unresectable, or metastatic disease based on most recent imaging.
•Part 1: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.
•Part 2:The respective cohorts for patient inclusion are:

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 for Part
•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.
•Medical conditions that may interfere with the subject's participation in the study.