A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors

Sponsor
AstraZeneca
Study ID
NCT06271837
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan — DRUG
    Trastuzumab deruxtecan by intravenous infusion
  • Bevacizumab — DRUG
    Bevacizumab by intravenous infusion

Study Details

This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan as monotherapy or in combination with anti-cancer agents for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2-expressing solid tumors which are not eligible for curative therapy.

Key Dates

Start date
Feb 22, 2024
Status verified
Apr 2026
Primary completion
Nov 28, 2025
Completion
Feb 10, 2027

Study Design

Enrollment
127 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
    HER2 IHC 3+ solid tumors (excluding breast and gastric cancer)
  • Experimental: Part 2 Cohort A
    HER2 IHC 2+ solid tumors (excluding breast and gastric cancer)
  • Experimental: Part 2 Cohort B
    HER2 IHC 1+ gynecologic cancers
  • Experimental: Part 3
    HER2 IHC 3+ or 2+ cervical cancer

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) [ Time Frame: An average of approximately 12 months ]