Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
NCT ID: NCT04379596
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
413 participants
INTERVENTIONAL
2020-06-03
2027-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
In addition to safety and tolerability, this study will also assess ORR, DoR, DCR, OS, PFS and other measures of antitumor activity among treatment groups. Tumor evaluation using RECIST v1.1 will be conducted at screening and every 6 weeks until RECIST 1.1 objective disease progression or withdrawal of consent.
TREATMENT
NONE
Study Groups
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Arm 1A
T-DXd and 5-fluorouracil (5-FU)
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Arm 1B
T-DXd and capecitabine
Capecitabine
Capecitabine: administered orally
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Arm 1C
T-DXd and durvalumab
Durvalumab
Durvalumab: administered as an IV infusion
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Arm 1D(b)
T-DXd, capecitabine, and oxaliplatin
Capecitabine
Capecitabine: administered orally
Oxaliplatin
Oxaliplatin: administered as an IV infusion
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Arm 1E(a)
T-DXd, 5-FU, and durvalumab
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Durvalumab
Durvalumab: administered as an IV infusion
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Arm 1E(b)
T-DXd, capecitabine, and durvalumab
Capecitabine
Capecitabine: administered orally
Durvalumab
Durvalumab: administered as an IV infusion
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Arm 2A
Trastuzumab, 5-FU or capecitabine, and cisplatin or oxaliplatin
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Capecitabine
Capecitabine: administered orally
Oxaliplatin
Oxaliplatin: administered as an IV infusion
Trastuzumab
Trastuzumab: administered as an IV infusion
Cisplatin
Cisplatin: administered as an IV infusion
Arm 2B
T-DXd monotherapy
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Arm 2C
T-DXd, 5-FU or capecitabine
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Capecitabine
Capecitabine: administered orally
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Arm 2D
T-DXd, pembrolizumab and 5-FU or capecitabine
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Capecitabine
Capecitabine: administered orally
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Pembrolizumab
Pembrolizumab: administered as an IV infusion
Arm 2E
T-DXd and pembrolizumab
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Pembrolizumab
Pembrolizumab: administered as an IV infusion
Arm 2F
T-DXd, pembrolizumab and 5-FU or capecitabine
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Capecitabine
Capecitabine: administered orally
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Pembrolizumab
Pembrolizumab: administered as an IV infusion
Arm 3A
T-DXd, Volrustomig and 5-FU or capecitabine
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Capecitabine
Capecitabine: administered orally
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Volrustomig
Volrustomig: administered as an IV infusion
Arm 3B
T-DXd, Volrustomig and 5-FU or capecitabine
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Capecitabine
Capecitabine: administered orally
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Volrustomig
Volrustomig: administered as an IV infusion
Arm 4A
T-DXd, Rilvegostomig and 5-FU or capecitabine
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Capecitabine
Capecitabine: administered orally
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Rilvegostomig
Rilvegostomig: administered as an IV infusion
Arm 4B
T-DXd, Rilvegostomig and 5-FU or capecitabine
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Capecitabine
Capecitabine: administered orally
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Rilvegostomig
Rilvegostomig: administered as an IV infusion
Part 5 Main Cohort
T-DXd, Volrustomig and 5-FU or capecitabine
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Capecitabine
Capecitabine: administered orally
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Volrustomig
Volrustomig: administered as an IV infusion
Part 5 Cohort 2
T-DXd, Volrustomig and 5-FU or capecitabine
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Capecitabine
Capecitabine: administered orally
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Volrustomig
Volrustomig: administered as an IV infusion
Interventions
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Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Capecitabine
Capecitabine: administered orally
Durvalumab
Durvalumab: administered as an IV infusion
Oxaliplatin
Oxaliplatin: administered as an IV infusion
Trastuzumab
Trastuzumab: administered as an IV infusion
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Cisplatin
Cisplatin: administered as an IV infusion
Pembrolizumab
Pembrolizumab: administered as an IV infusion
Volrustomig
Volrustomig: administered as an IV infusion
Rilvegostomig
Rilvegostomig: administered as an IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Disease Characteristics:
1. Locally advanced, unresectable, or metastatic disease based on most recent imaging
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
3. 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
3. 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
4. Has measurable target disease assessed by the Investigator based on RECIST version 1.1
5. Has protocol defined adequate bone marrow and organ function including cardiac, renal and hepatic function
6. 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
2. Uncontrolled intercurrent illness.
3. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
4. Lung-specific intercurrent clinically significant severe illnesses.
5. Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
6. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
7. Has spinal cord compression or clinically active central nervous system metastases.
18 Years
130 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Santa Monica, California, United States
Research Site
Westwood, Kansas, United States
Research Site
Baltimore, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
New York, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Houston, Texas, United States
Research Site
Fairfax, Virginia, United States
Research Site
Florianópolis, , Brazil
Research Site
Londrina, , Brazil
Research Site
Natal, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Ribeirão Preto, , Brazil
Research Site
Rio de Janeiro, , Brazil
Research Site
Santa Maria, , Brazil
Research Site
São Jose Do Rio Preto, , Brazil
Research Site
São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Edmonton, Alberta, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Chengdu, , China
Research Site
Guangzhou, , China
Research Site
Guiyang, , China
Research Site
Hangzhou, , China
Research Site
Hefei, , China
Research Site
Hefei, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Ürümqi, , China
Research Site
Wuhan, , China
Research Site
Xiamen, , China
Research Site
Zhengzhou, , China
Research Site
Frankfurt, , Germany
Research Site
Frankfurt, , Germany
Research Site
Hamburg, , Germany
Research Site
Leipzig, , Germany
Research Site
Mannheim, , Germany
Research Site
München, , Germany
Research Site
Milan, , Italy
Research Site
Milan, , Italy
Research Site
Napoli, , Italy
Research Site
Padua, , Italy
Research Site
Roma, , Italy
Research Site
Verona, , Italy
Research Site
Chūōku, , Japan
Research Site
Kashiwa, , Japan
Research Site
Kita-gun, , Japan
Research Site
Ota-shi, , Japan
Research Site
Amsterdam, , Netherlands
Research Site
Amsterdam, , Netherlands
Research Site
Utrecht, , Netherlands
Research Site
Gdansk, , Poland
Research Site
Konin, , Poland
Research Site
Koszalin, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Opole, , Poland
Research Site
Tomaszów Mazowiecki, , Poland
Research Site
Warsaw, , Poland
Research Site
Kostroma, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Seongnam-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Santander, , Spain
Research Site
Seville, , Spain
Research Site
Kaohsiung City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Tainan, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Cambridge, , United Kingdom
Research Site
Dundee, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Sutton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2019-004483-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D967LC00001
Identifier Type: -
Identifier Source: org_study_id
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