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
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|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||None (open-label)|
|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|
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan (T-DXd) by intravenous infusion
Other Name: DS-8201a (T-DXd)
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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.
|Ages Eligible for Study:||18 Years to 120 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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
|United States, California|
|Santa Rosa, California, United States, 95403|
|United States, Indiana|
|Muncie, Indiana, United States, 47303|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|Boston, Massachusetts, United States, 02215|
|United States, New Jersey|
|Middletown, New Jersey, United States, 07748|
|United States, New York|
|Commack, New York, United States, 11725|
|Harrison, New York, United States, 10604|
|New York, New York, United States, 10021|
|United States, Texas|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|Fairfax, Virginia, United States, 22031|
|Anderlecht, Belgium, 1070|
|Toronto, CA, Canada, M5G 2M9|
|Copenhagen, Denmark, 2100|
|Bordeaux, France, 33076|
|Lyon Cedex 08, France, 69008|
|Villejuif, France, 94805|
|Milano, Italy, 20162|
|Milan, Italy, 20141|
|Napoli, Italy, 80131|
|Chuo-ku, Japan, 104-0045|
|Kashiwa, Japan, 277-8577|
|Suita-shi, Japan, 565-0871|
|Korea, Republic of|
|Seoul, Korea, Republic of, 03080|
|Seoul, Korea, Republic of, 03722|
|Seoul, Korea, Republic of, 06351|
|Barcelona, Spain, 08035|
|Madrid, Spain, 28041|
|Madrid, Spain, 28050|
|Pamplona, Spain, 31008|
|Sevilla, Spain, 41013|
|Other Study ID Numbers:||
|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|
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.
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.|
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.
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Antineoplastic Agents, Immunological