A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer

Sponsor
Janssen Pharmaceutical K.K.
Study ID
NCT04945733
Phase
PHASE2
Status
Terminated

Conditions

  • Esophageal Neoplasms
  • Stomach Neoplasms

Eligibility Criteria

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

Interventions

  • Amivantamab — DRUG
    Amivantamab will be administered intravenously.

Study Details

The purpose of this study is to investigate the activity of amivantamab in gastric cancer (GC) and esophageal cancer (EC) participants (Phase 2a), and to characterize the preliminary antitumor activity of amivantamab in selected GC and EC population (Phase 2b).

Key Dates

Start date
Aug 30, 2021
Status verified
Aug 2024
Primary completion
Jul 3, 2023
Completion
Jul 3, 2023

Study Design

Enrollment
62 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Amivantamab: Gastric Cancer (GC) Cohorts
    Participants in Phase 2a GC cohorts will receive intravenous (IV) infusion of weight-based dose of amivantamab in 28-day cycles. Participants with body weight less than (\<) 80 kilograms (kg) will receive IV infusion of amivantamab 1,050 milligrams (mg) and participants with body weight greater than or equal to (\>=) 80 kg will receive IV infusion of amivantamab 1,400 mg once weekly in Cycle 1 and then every 2 weeks in subsequent cycles (on Days 1 and 15 of each cycle), followed by additional dosing based on body weight if recommended by clinical trial management team (CTMT) (amivantamab 1750 mg for body weight \<80 kg and 2100 mg for body weight \>=80 kg as IV infusion) every 2 weeks on Days 1 and 15 of 28 day cycle. Phase 2b GC expansion cohorts will be initiated if activity is observed within Phase 2a cohorts.
  • Experimental: Amivantamab: Esophageal Cancer (EC) Cohorts
    Participants in Phase 2a EC cohorts will receive IV infusion of weight-based dose of amivantamab in 28-day cycles. Participants with body weight \<80 kg will receive IV infusion of amivantamab 1,050 mg and participants with body weight \>=80 kg will receive IV infusion of amivantamab 1,400 mg once weekly in Cycle 1 and then every 2 weeks in subsequent cycles (on Days 1 and 15 of each cycle) followed by additional dosing based on body weight if recommended by CTMT (amivantamab 1750 mg for body weight \<80 kg and 2100 mg for body weight \>=80 kg as IV infusion) every 2 weeks on Days 1 and 15 of 28 day cycle. Phase 2b EC expansion cohorts will be initiated if activity is observed within Phase 2a cohorts.

Primary Outcome Measure

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 [ Time Frame: From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months) ]

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