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Clinical Trials in Italy / NCT04379596
Active, not recruiting Phase 2

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

NCT04379596 · tracked via the Priya Life Science Italy tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2020-06-03
Last updated
2026-08-28

Condition(s) studied

Gastric Cancer

Investigational drug(s) / intervention(s)

Fluorouracil (5-FU) →Capecitabine →Durvalumab →Oxaliplatin →Trastuzumab →Trastuzumab deruxtecan →Cisplatin →Pembrolizumab →Volrustomig →Rilvegostomig →

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion criteria: 1. Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations 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: 1. 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. 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.

Primary outcome measure(s)

  • Part 1: Occurrence of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0 — Safety will be assessed up to the follow-up period, approximately 24 months.
    Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0
  • Part 1: Ocurrence of dose-limiting toxicities (DLTs) — Safety will be assessed up to the follow-up period, approximately 24 months.
    Occurrence of dose limiting toxicities
  • Part 1: Changes from baseline in laboratory parameters — Safety will be assessed up to the follow-up period, approximately 24 months.
    Changes in laboratory parameters (every in appropriate units) compared to baseline results.
  • Part 1: Changes from baseline in vital signs — Safety will be assessed up to the follow-up period, approximately 24 months.
    Changes in vital signs results compared to baseline results.
  • Part 1: Changes from baseline in electrocardiogram (ECG) results — Safety will be assessed up to the follow-up period, approximately 24 months.
    Changes in ECG results compared to baseline results.
  • Part 2, Part 3, Part 4 and Part 5: Endpoint assessed by Investigator per RECIST v1.1: Confirmed Objective Response Rate (ORR) — (Endpoint: ORR) Efficacy will be assessed at an average of approximately 12 months
    Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.

Trial sites (71)

FacilityCityRegionStatus
Research Site Baltimore Maryland
Research Site Boston Massachusetts
Research Site New York New York
Research Site Houston Texas
Research Site Londrina Brazil
Research Site Ribeirão Preto Brazil
Research Site Santa Maria Brazil
Research Site São Jose Do Rio Preto Brazil
Research Site São Paulo Brazil
Research Site Toronto Ontario
Research Site Montreal Quebec
Research Site Québec Quebec
Research Site Chengdu China
Research Site Guangzhou China
Research Site Hefei China
Research Site Shanghai China
Research Site Shenyang China
Research Site Wuhan 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 Naples Italy
Research Site Padova Italy
Research Site Roma Italy
Research Site Verona Italy
Research Site Chūōku Japan
Research Site Kashiwa 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

+ 31 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile → 📄 Herceptin (trastuzumab) drug profile → 📄 Enhertu (trastuzumab deruxtecan) drug profile → 📄 Keytruda (pembrolizumab) drug profile →

More AstraZeneca trials in Italy

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A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer Recruiting
AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer Recruiting
Acalabrutinib Real World Italian obSErvational Study -ARISE Active, not recruiting
Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy Active, not recruiting

Other trials for the same condition

A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors Recruiting
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Recruiting
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) Active, not recruiting
Genomic and Dietary Aspects in Gastric Cancer Risk Starting soon
AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04379596 on ClinicalTrials.gov ↗ ← All trials in Italy