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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04639219
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : March 24, 2021
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
AstraZeneca

Brief 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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast Drug: Trastuzumab deruxtecan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: None (open-label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 30, 2020
Estimated Primary Completion Date : November 28, 2022
Estimated Study Completion Date : November 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: T-DXd
T-DXd monotherapy
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan (T-DXd) by intravenous infusion
Other Name: DS-8201a (T-DXd)




Primary Outcome Measures :
  1. Confirmed objective response rate by RECIST 1.1 based on independent central review (ICR). [ Time Frame: An average of approximately 12 months. ]
    Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed, based on ICR.


Secondary Outcome Measures :
  1. Duration of response (DoR) based on ICR assessment. [ Time Frame: An average of approximately 12 months. ]
    DOR is defined as the time from the date of first documented response until the date of documented progression or death, based on ICR assessment.

  2. Disease control rate (DCR) based on ICR assessment. [ Time Frame: An average of approximately 12 months. ]
    DCR is the percentage of patients who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD), based on ICR assessment.

  3. Progression free survival (PFS) based on ICR assessment. [ Time Frame: An average of approximately 12 months. ]
    PFS is the time from first dose of study treatment until the date of objective disease progression or death, based on ICR assessment.

  4. Confirmed Objective Response Rate (ORR) based on investigator assessment. [ Time Frame: An average of approximately 12 months. ]
    Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed, based on investigator assessment

  5. Overall survival (OS). [ Time Frame: An average of approximately 20 months. ]
    OS is the time form the date of first dose of study treatment until death due to any cause.

  6. Occurrence of adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: An average of approximately 14 months. ]
    Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.

  7. Serum concentration of T-DXd. [ Time Frame: An average of approximately 14 months. ]
    Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd.

  8. Serum concentration of total anti-HER2 antibody. [ Time Frame: An average of approximately 14 months. ]
    Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for total anti-HER2 antibody.

  9. Serum concentration of MAAA-1181a. [ Time Frame: An average of approximately 14 months. ]
    Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for MAAA-1181a.

  10. The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd. [ Time Frame: An avarage of approximately 14 months. ]
    Individual participant data and descriptive statistics will be provided for data at each time point.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04639219


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, California
Research Site Not yet recruiting
Fullerton, California, United States, 92835
Research Site Not yet recruiting
La Jolla, California, United States, 92093
Research Site Not yet recruiting
Santa Rosa, California, United States, 95403
United States, Illinois
Research Site Not yet recruiting
Chicago, Illinois, United States, 60647
United States, Indiana
Research Site Not yet recruiting
Muncie, Indiana, United States, 47303
United States, Massachusetts
Research Site Not yet recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Research Site Not yet recruiting
Detroit, Michigan, United States, 48201
United States, New York
Research Site Not yet recruiting
New York, New York, United States, 10021
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Research Site Not yet recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Research Site Not yet recruiting
Seattle, Washington, United States, 98109
Belgium
Research Site Not yet recruiting
Bruxelles, Belgium, 1000
Research Site Not yet recruiting
Edegem, Belgium, 2650
Canada, CA
Research Site Not yet recruiting
Toronto, CA, Canada, M5G 2M9
Canada
Research Site Withdrawn
Montreal, Canada, H3T 1E2
Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of, 03722
Research Site Recruiting
Seoul, Korea, Republic of, 06351
Research Site Recruiting
Seoul, Korea, Republic of, 110-744
Spain
Research Site Recruiting
Barcelona, Spain, 08035
Research Site Not yet recruiting
Barcelona, Spain, 8003
Research Site Not yet recruiting
Madrid, Spain, 28041
Research Site Not yet recruiting
Pamplona, Spain, 31008
Research Site Not yet recruiting
Sevilla, Spain, 41013
Sponsors and Collaborators
AstraZeneca
Daiichi Sankyo Co., Ltd.
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04639219    
Other Study ID Numbers: D967MC00001
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria:

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool .

Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.

For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
HER2
T-DXd
DS-8201a
Trastuzumab Deruxtecan
Metastatic
Solid Tumors
Histology Agnostic
Additional relevant MeSH terms:
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Neoplasms
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents