Status:
RECRUITING
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-130 years
Phase:
PHASE2
Brief Summary
DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemoth...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations
- Disease Characteristics:
- Locally advanced, unresectable, or metastatic disease based on most recent imaging
- 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
- For Part 3b,4b and Part 5, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results
- For Part 1, progression on or after at least one prior trastuzumabcontaining regimen For Part 2, Part 3, Part 4 and Part 5, 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 \[Arm 3B\], Part 4 \[Arm 4B\] and Part 5)) status
- Has measurable target disease assessed by the Investigator based on RECIST version 1.1
- Has protocol defined adequate bone marrow and organ function including cardiac, renal and hepatic function
- If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study.
- Exclusion criteria:
- Part 1 to 4: History of active primary immunodeficiency, known HIV, active chronic, or past hepatitis B infection, or hepatitis C infection. Part 5: evidence of active, uncontroled HIV, HBV or HCV infection.
- Uncontrolled intercurrent illness.
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
June 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT04379596
Start Date
June 3 2020
End Date
June 1 2027
Last Update
December 2 2025
Active Locations (100)
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1
Research Site
Santa Monica, California, United States, 90404
2
Research Site
Westwood, Kansas, United States, 66205
3
Research Site
Baltimore, Maryland, United States, 21287
4
Research Site
Boston, Massachusetts, United States, 02114