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A Study of IMU-131 (HER-Vaxx) in Combination With Chemotherapy or Pembrolizumab in Patients With Metastatic HER2/Neu Over-Expressing Gastric Cancer (nextHERIZON)

NCT05311176 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-05-11

Study results available
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Summary

This is a Phase 2, signal generating, open-label, 2-Arm, non-randomized study, in patients with metastatic HER2/neu over-expressing gastric cancer or gastroesophageal adenocarcinomas.

Conditions

  • Gastric Cancer
  • Cancer of Stomach
  • Gastric Adenocarcinoma
  • Stomach Cancer
  • Stomach Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Interventions

BIOLOGICAL

IMU-131

IMU-131 will be administered intramuscularly into the deltoid region of the arm on Day 1, 15, 29 and 57 and then every 63 days until disease progression or treatment discontinuation.

DRUG

Ramucirumab plus Paclitaxel

Chemotherapy to be administered every 3 weeks (Q3W) starting on Day 1.

BIOLOGICAL

Pembrolizumab

Pembrolizumab will be administered every 3 weeks (Q3W) starting on Day 1 until disease progression or treatment discontinuation.

Sponsors & Collaborators

  • Imugene Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2024-04-04
Completion
2024-04-04
FDA Drug
Yes

Countries

  • Australia
  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05311176 on ClinicalTrials.gov