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Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens (DG-06)

Primary Purpose

Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Trastuzumab Deruxtecan
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma focused on measuring Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, HER2, Trastuzumab, Deruxtecan, T-DXd, DS-8201a, ERBB2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female ≥ 18 years of age
  2. Pathologically documented gastric or GEJ adenocarcinoma
  3. Disease progression on or after ≥ 2 prior platinum and fluoropyrimidine agents for advanced/metastatic disease
  4. ECOG PS 0-1
  5. Willing and able to provide an adequate newly-acquired tumour sample for confirmation of HER2 status
  6. LVEF ≥ 50%

Exclusion Criteria:

  1. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and CART. Drainage and CART.
  2. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids
  3. Active primary immunodeficiency, known HIV, active HBV, HCV infection.
  4. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
  5. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
  6. Lung-specific intercurrent clinically significant severe illnesses.

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

T-DXd arm

Arm Description

T-DXd monotherapy

Outcomes

Primary Outcome Measures

Confirmed objective response rate by RECIST 1.1 based on independent central review (ICR)
Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by ICR per RECIST 1.1.

Secondary Outcome Measures

investigator-assessed ORR
Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1
PFS
PFS is defined as time from date of enrolment until progression per RECIST 1.1 as assessed by ICR or death due to any cause. PFS will be evaluated based on ICR and on investigator assessment.
DCR
DCR is defined as the percentage of participants who have a confirmed CR/PR or SD(without subsequent anticancer therapy) after date of enrolment.DCR will be evaluated based on ICR and on investigator assessment.
DoR
DoR is defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression. DoR will be evaluated based on ICR and on investigator assessment.
OS
OS is defined as time from date of enrolment until the date of death due to any cause
Tumour size change
Tumour size change will be evaluated based on ICR and investigator assessment.
Serum concentrations of T-DXd
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.
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.
Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for MAAA-1181a.
Immunogenicity
Presence of ADAs against T-DXd in serum during treatment (before infusion on Day 1 of Cycles 1, 2, and 4, and every 4 cycles thereafter) and at follow-up. Neutralising ADAs will also be assessed

Full Information

First Posted
July 14, 2021
Last Updated
July 17, 2023
Sponsor
AstraZeneca
Collaborators
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04989816
Brief Title
Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens
Acronym
DG-06
Official Title
A Single-arm Study of Trastuzumab Deruxtecan (T-DXd) Monotherapy for Patients With HER2-expressing Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Who Have Received 2 or More Prior Regimens (DESTINY-Gastric06)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Daiichi Sankyo Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase II, open-label, single-arm, multicentre, study in China assessing the efficacy and safety of T-DXd in participants with HER2-expressing advanced gastric or GEJ adenocarcinoma who have received at least 2 prior regimens including a fluoropyrimidine agent and a platinum agent

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Keywords
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, HER2, Trastuzumab, Deruxtecan, T-DXd, DS-8201a, ERBB2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single group assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T-DXd arm
Arm Type
Experimental
Arm Description
T-DXd monotherapy
Intervention Type
Drug
Intervention Name(s)
Trastuzumab Deruxtecan
Other Intervention Name(s)
DS8201a; AZD4552; T-DXd
Intervention Description
Trastuzumab deruxtecan (T-DXd) by intravenous infusion
Primary Outcome Measure Information:
Title
Confirmed objective response rate by RECIST 1.1 based on independent central review (ICR)
Description
Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by ICR per RECIST 1.1.
Time Frame
An average of approximately 14 months
Secondary Outcome Measure Information:
Title
investigator-assessed ORR
Description
Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1
Time Frame
An average of approximately 14 months
Title
PFS
Description
PFS is defined as time from date of enrolment until progression per RECIST 1.1 as assessed by ICR or death due to any cause. PFS will be evaluated based on ICR and on investigator assessment.
Time Frame
An average of approximately 14 months
Title
DCR
Description
DCR is defined as the percentage of participants who have a confirmed CR/PR or SD(without subsequent anticancer therapy) after date of enrolment.DCR will be evaluated based on ICR and on investigator assessment.
Time Frame
Approximately 6 weeks
Title
DoR
Description
DoR is defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression. DoR will be evaluated based on ICR and on investigator assessment.
Time Frame
An average of approximately 14 months
Title
OS
Description
OS is defined as time from date of enrolment until the date of death due to any cause
Time Frame
At least 16 months
Title
Tumour size change
Description
Tumour size change will be evaluated based on ICR and investigator assessment.
Time Frame
An average of approximately 14 months
Title
Serum concentrations of T-DXd
Description
Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd.
Time Frame
An average of approximately 14 months
Title
Serum concentration of total anti-HER2 antibody.
Description
Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for total anti-HER2 antibody.
Time Frame
An average of approximately 14 months.
Title
Serum concentration of MAAA-1181a.
Description
Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for MAAA-1181a.
Time Frame
An average of approximately 14 months.
Title
Immunogenicity
Description
Presence of ADAs against T-DXd in serum during treatment (before infusion on Day 1 of Cycles 1, 2, and 4, and every 4 cycles thereafter) and at follow-up. Neutralising ADAs will also be assessed
Time Frame
An average of approximately 14 months
Other Pre-specified Outcome Measures:
Title
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Description
Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0
Time Frame
On average of approximately 16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ≥ 18 years of age Pathologically documented gastric or GEJ adenocarcinoma Disease progression on or after ≥ 2 prior platinum and fluoropyrimidine agents for advanced/metastatic disease ECOG PS 0-1 Willing and able to provide an adequate newly-acquired tumour sample for confirmation of HER2 status LVEF ≥ 50% Exclusion Criteria: Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and CART. Drainage and CART. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids Active primary immunodeficiency, known HIV, active HBV, HCV infection. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening. Lung-specific intercurrent clinically significant severe illnesses.
Facility Information:
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610042
Country
China
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350014
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510062
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310020
Country
China
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230001
Country
China
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230031
Country
China
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250001
Country
China
Facility Name
Research Site
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Facility Name
Research Site
City
Nan Chong
ZIP/Postal Code
637000
Country
China
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330029
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
Research Site
City
Suzhou
ZIP/Postal Code
215006
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430000
Country
China
Facility Name
Research Site
City
Xiamen
ZIP/Postal Code
361003
Country
China
Facility Name
Research Site
City
Yinchuan
ZIP/Postal Code
750004
Country
China
Facility Name
Research Site
City
Zhengzhou City
ZIP/Postal Code
450000
Country
China
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 requests 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.
IPD Sharing 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.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . A 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens

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