A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations (DPT01)

  • STATUS
    Recruiting
  • End date
    Dec 28, 2022
  • participants needed
    100
  • sponsor
    AstraZeneca
Updated on 5 May 2022

Summary

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

Details
Condition Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast
Treatment Trastuzumab deruxtecan
Clinical Study IdentifierNCT04639219
SponsorAstraZeneca
Last Modified on5 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults ≥18 years old. Other age restrictions may apply as per local regulations
Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations locally determined by NGS, who have progressed following prior treatment or who have no satisfactory alternative treatment options
Prior HER2 targeted therapy is permitted
All patients must provide an FFPE tumor sample for retrospective central HER2 testing
LVEF ≥50%
ECOG 0-1

Exclusion Criteria

HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma
HER2 mutant NSCLC
History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening
Lung-specific intercurrent clinically significant severe illnesses
History of active primary immunodeficiency, known HIV, active HBV or HCV infection
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)
Has spinal cord compression or clinically active central nervous system metastases
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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