RECRUITING

Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

Talk to us

Conditions

Gastric CancerEsophageal CancerCarcinomaHER2TrastuzumabDeruxtecanT-DXdDS-8201aGastroesophageal CancerAdenocarcinoma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients. Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-expressing gastric, GEJ and esophageal cancer patients who have not received prior treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.

Official Title

A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)

Quick Facts

Study Start:2020-06-03
Study Completion:2026-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04379596

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 130 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations
  2. 2. Disease Characteristics:
  3. 1. Locally advanced, unresectable, or metastatic disease based on most recent imaging
  4. 2. For Part 1, 2, 3a, 4a pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local tissue testing results
  5. 3. For Part 3b and 4b, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results
  6. 3. For Part 1, progression on or after at least one prior trastuzumabcontaining regimen For Part 2, Part 3 and Part 4, previously untreated for unresectable or metastatic adenocarcinoma of the stomach/GEJ/ esophagus with with HER2-positive (Part 2 and Part 3 \[Arm 3A\] and Part 4 \[Arm 4A\]) or HER2-low (Part 3 \[Arm 3B\] and Part 4 \[Arm 4B\])) status
  7. 4. Has measurable target disease assessed by the Investigator based on RECIST version 1.1
  8. 5. Has protocol defined adequate bone marrow and organ function including cardiac, renal and hepatic function
  9. 6. If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study.
  1. 1. History of active primary immunodeficiency, known HIV, active chronic, or past hepatitis B infection, or hepatitis C infection.
  2. 2. Uncontrolled intercurrent illness
  3. 3. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
  4. 4. Lung-specific intercurrent clinically significant severe illnesses.
  5. 5. Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
  6. 6. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
  7. 7. Has spinal cord compression or clinically active central nervous system metastases.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Research Site
Santa Monica, California, 90404
United States
Research Site
Westwood, Kansas, 66205
United States
Research Site
Baltimore, Maryland, 21287
United States
Research Site
Boston, Massachusetts, 02114
United States
Research Site
Boston, Massachusetts, 02215
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
New York, New York, 10065
United States
Research Site
Durham, North Carolina, 27710
United States
Research Site
Houston, Texas, 77090
United States
Research Site
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-03
Study Completion Date2026-07-30

Study Record Updates

Study Start Date2020-06-03
Study Completion Date2026-07-30

Terms related to this study

Keywords Provided by Researchers

  • Gastric Cancer
  • Esophageal Cancer
  • Carcinoma
  • HER2
  • Trastuzumab
  • Deruxtecan
  • T-DXd
  • DS-8201a
  • Gastroesophageal Cancer
  • Adenocarcinoma

Additional Relevant MeSH Terms

  • Gastric Cancer