OncRef

Clinical Trial: NCT04482309

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:AstraZeneca
Information Provided By:AstraZeneca
Last Update Posted:2026-07-10

Study 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.

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)

Conditions

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

Intervention / Treatment

  • Drug: Trastuzumab deruxtecan

Other Study ID Numbers

  • D967VC00001
  • 2023-504721-39-02
  • 2020-001574-29
  • 2023

Start Date (Actual)

2020-08-18

Primary Completion Date (Estimated)

2027-03-23

Study Completion Date (Estimated)

2027-03-23

Enrollment (Actual)

477

Study Type

Interventional

Phase

Phase 2