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

Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04989816
• Other study ID #: D9676C00002
• Status: Completed
• Phase: Phase 2
• Start date: August 20, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: February 28, 2024
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Intervention

Drug:
• Trastuzumab Deruxtecan
Trastuzumab deruxtecan (T-DXd) by intravenous infusion

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Changsha
China	Research Site	Chengdu
China	Research Site	Fuzhou
China	Research Site	Guangzhou
China	Research Site	Hangzhou
China	Research Site	Hangzhou
China	Research Site	Hangzhou
China	Research Site	Hefei
China	Research Site	Hefei
China	Research Site	Jinan
China	Research Site	Lanzhou
China	Research Site	Nan Chong
China	Research Site	Nanchang
China	Research Site	Nanjing
China	Research Site	Shanghai
China	Research Site	Shenyang
China	Research Site	Suzhou
China	Research Site	Wuhan
China	Research Site	Xiamen
China	Research Site	Yinchuan
China	Research Site	Zhengzhou
China	Research Site	Zhengzhou City

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of adverse events (AEs) and serious adverse events (SAEs)	Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0	On average of approximately 16 months
Primary	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.	An average of approximately 14 months
Secondary	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	An average of approximately 14 months
Secondary	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.	An average of approximately 14 months
Secondary	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.	Approximately 6 weeks
Secondary	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.	An average of approximately 14 months
Secondary	OS	OS is defined as time from date of enrolment until the date of death due to any cause	At least 16 months
Secondary	Tumour size change	Tumour size change will be evaluated based on ICR and investigator assessment.	An average of approximately 14 months
Secondary	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.	An average of approximately 14 months
Secondary	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.	An average of approximately 14 months.
Secondary	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.	An average of approximately 14 months.
Secondary	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	An average of approximately 14 months