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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04639219
Recruitment Status : Active, not recruiting
First Posted : November 20, 2020
Last Update Posted : March 8, 2023
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Non-Randomized
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
Actual Primary Completion Date : January 25, 2023
Estimated Study Completion Date : January 17, 2028

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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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)


Outcome Measures
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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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
Contacts and Locations
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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


Locations
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United States, California
Research Site
Santa Rosa, California, United States, 95403
United States, Indiana
Research Site
Muncie, Indiana, United States, 47303
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02115
Research Site
Boston, Massachusetts, United States, 02215
United States, New Jersey
Research Site
Middletown, New Jersey, United States, 07748
United States, New York
Research Site
Commack, New York, United States, 11725
Research Site
Harrison, New York, United States, 10604
Research Site
New York, New York, United States, 10021
United States, Texas
Research Site
Houston, Texas, United States, 77030
United States, Virginia
Research Site
Fairfax, Virginia, United States, 22031
Belgium
Research Site
Anderlecht, Belgium, 1070
Canada, CA
Research Site
Toronto, CA, Canada, M5G 2M9
Denmark
Research Site
Copenhagen, Denmark, 2100
France
Research Site
Bordeaux, France, 33076
Research Site
Lyon Cedex 08, France, 69008
Research Site
Villejuif, France, 94805
Italy
Research Site
Milano, Italy, 20162
Research Site
Milan, Italy, 20141
Research Site
Napoli, Italy, 80131
Japan
Research Site
Chuo-ku, Japan, 104-0045
Research Site
Kashiwa, Japan, 277-8577
Research Site
Suita-shi, Japan, 565-0871
Korea, Republic of
Research Site
Seoul, Korea, Republic of, 03080
Research Site
Seoul, Korea, Republic of, 03722
Research Site
Seoul, Korea, Republic of, 06351
Spain
Research Site
Barcelona, Spain, 08035
Research Site
Madrid, Spain, 28041
Research Site
Madrid, Spain, 28050
Research Site
Pamplona, Spain, 31008
Research Site
Sevilla, Spain, 41013
Sponsors and Collaborators
AstraZeneca
Daiichi Sankyo Co., Ltd.
More Information
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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 8, 2023
Last Verified: March 2023
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
Trastuzumab deruxtecan
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs