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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• Trastuzumab deruxtecan — DRUG
  Trastuzumab deruxtecan by intravenous infusion

Study Details

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.

Key Dates

Start date

Aug 18, 2020

Status verified

Apr 2026

Primary completion

Mar 23, 2027

Completion

Mar 23, 2027

Study Design

Enrollment

477 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 Cohort 1
  Biliary tract cancer
• Experimental: Part 1 Cohort 2
  Bladder cancer
• Experimental: Part 1 Cohort 3
  Cervical cancer
• Experimental: Part 1 Cohort 4
  Endometrial cancer
• Experimental: Part 1 Cohort 5
  Ovarian cancer
• Experimental: Part 1 Cohort 6
  Pancreatic cancer
• Experimental: Part 1 Cohort 7
  Rare tumors
• Experimental: Part 2 Cohort A
  Any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer)
• Experimental: Part 2 Cohort B
  Any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer)
• Experimental: Part 2 Cohort C
  HER2 IHC 2+ or 1+ endometrial cancer
• Experimental: Part 2 Cohort D
  HER2 IHC 2+ or 1+ ovarian cancer
• Experimental: Part 2 Cohort E
  HER2 IHC 2+ or 1+ cervical cancer

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: An average of approximately 6 months ]

Locations (12)

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