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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
AstraZeneca
Study ID
NCT04379596
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Fluorouracil (5-FU) — DRUG
    5-FU: administered as an IV infusion
  • Capecitabine — DRUG
    Capecitabine: administered orally
  • Durvalumab — BIOLOGICAL
    Durvalumab: administered as an IV infusion
  • Oxaliplatin — DRUG
    Oxaliplatin: administered as an IV infusion
  • Trastuzumab — BIOLOGICAL
    Trastuzumab: administered as an IV infusion
  • Trastuzumab deruxtecan — DRUG
    T-DXd: administered as an IV infusion
  • Cisplatin — DRUG
    Cisplatin: administered as an IV infusion
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab: administered as an IV infusion
  • Volrustomig — BIOLOGICAL
    Volrustomig: administered as an IV infusion
  • Rilvegostomig — BIOLOGICAL
    Rilvegostomig: administered as an IV infusion

Study Details

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.

Key Dates

First listed
May 7, 2020
Start date
Jun 3, 2020
Status verified
Aug 2026
Primary completion
May 4, 2027
Completion
May 4, 2027

Study Design

Enrollment
452 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1A
    T-DXd and 5-fluorouracil (5-FU)
  • Experimental: Arm 1B
    T-DXd and capecitabine
  • Experimental: Arm 1C
    T-DXd and durvalumab
  • Experimental: Arm 1D(b)
    T-DXd, capecitabine, and oxaliplatin
  • Experimental: Arm 1E(a)
    T-DXd, 5-FU, and durvalumab
  • Experimental: Arm 1E(b)
    T-DXd, capecitabine, and durvalumab
  • Active Comparator: Arm 2A
    Trastuzumab, 5-FU or capecitabine, and cisplatin or oxaliplatin
  • Experimental: Arm 2B
    T-DXd monotherapy
  • Experimental: Arm 2C
    T-DXd, 5-FU or capecitabine
  • Experimental: Arm 2D
    T-DXd, pembrolizumab and 5-FU or capecitabine
  • Experimental: Arm 2E
    T-DXd and pembrolizumab
  • Experimental: Arm 2F
    T-DXd, pembrolizumab and 5-FU or capecitabine
  • Experimental: Arm 3A
    T-DXd, Volrustomig and 5-FU or capecitabine
  • Experimental: Arm 3B
    T-DXd, Volrustomig and 5-FU or capecitabine
  • Experimental: Arm 4A
    T-DXd, Rilvegostomig and 5-FU or capecitabine
  • Experimental: Arm 4B
    T-DXd, Rilvegostomig and 5-FU or capecitabine
  • Experimental: Part 5 Main Cohort
    T-DXd, Volrustomig and 5-FU or capecitabine
  • Experimental: Part 5 Cohort 2
    T-DXd, Volrustomig and 5-FU or capecitabine

Primary Outcome Measure

Part 1: Occurrence of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0 [ Time Frame: Safety will be assessed up to the follow-up period, approximately 24 months. ]

Locations (4)

FacilityCityStateZIPSite coordinators
Research SiteBaltimoreMaryland21287-
Research SiteBostonMassachusetts02215-
Research SiteNew YorkNew York10065-
Research SiteHoustonTexas77090-

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