Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junction Adenocarcinoma

Sponsor
National Cancer Center Hospital East
Study ID
NCT07529613
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • T-DXd — DRUG
    T-DXd (4.4mg/kg, intravenous, q3w)
  • Nivolumab — DRUG
    Nivolumab (360 mg, intravenous, q3w)
  • Capecitabine — DRUG
    Capecitabine (750mg/m2 twice daily, days 1-14, orally)
  • Oxaliplatin — DRUG
    Oxaliplatin (70mg/m2, intravenous, q3w)

Study Details

To evaluate the safety and tolerability of the combination therapy of T-DXd, nivolumab, and chemotherapy in patients with untreated HER2-low gastric or gastroesophageal junction adenocarcinoma, and to determine the recommended dose. Subsequently, the efficacy and safety at the recommended dose will be assessed.

Key Dates

Start date
Dec 20, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: T-DXd plus Nivolumab, Capecitabine

Primary Outcome Measure

Incidence of DLTs in Phase Ib part [ Time Frame: 3 weeks ]

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