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Protocol # 20-650

Status

Active, not recruiting

Description

This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted

Condition

  • Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast

Interventions

  • Trastuzumab deruxtecan

Phase

Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Confirmed objective response rate by RECIST 1.1 based on independent central review (ICR).

Secondary Outcome:

  • Duration of response (DoR) based on ICR assessment.
  • Disease control rate (DCR) based on ICR assessment.
  • Progression free survival (PFS) based on ICR assessment.
  • Confirmed Objective Response Rate (ORR) based on investigator assessment.
  • Overall survival (OS).
  • Occurrence of adverse events (AEs) and serious adverse events (SAEs).
  • Serum concentration of T-DXd.
  • Serum concentration of total anti-HER2 antibody.
  • Serum concentration of MAAA-1181a.
  • The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd.

Enrollment

102

Study Start Date

December 30, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     120 Years
  • Healthy volunteers:     No

Sponsors

AstraZeneca

Source

AstraZeneca

Official title

A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology

Clinicaltrials.gov Identifier

NCT04639219

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.