NCT05311176

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

nextHERIZON: An Open-Label, Signal Generating, Phase 2 Study of HER-Vaxx in Combination With Chemotherapy or Pembrolizumab in Patients With Metastatic HER2/Neu Over-Expressing Gastric or Gastroesophageal Junction (GEJ) Adenocarcinomas Who Have Previously Received Trastuzumab and Progressed on This Treatment

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Imugene Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

It is hypothesized that the introduction of HER-Vaxx after 1L treatment in patients that have progressed under trastuzumab may overcome potential resistance against trastuzumab in combination with chemotherapy and can be continued after chemotherapy is terminated. Based on pre-clinical data HER-Vaxx may also synergize with pembrolizumab and therefore serve as a potentially better tolerated and chemotherapy-free treatment opportunity in metastatic patients that progressed under their previous therapy. The study is designed to generate safety data and efficacy signals to support further development of HER-Vaxx in ≥2L mGC/GEJ cancer after progression with trastuzumab. The study includes two treatment arms that will be analyzed independently using a 2-Stage design: * Arm 1: HER-Vaxx in combination with chemotherapy (ramucirumab plus paclitaxel) * Arm 2: HER-Vaxx in combination with pembrolizumab. All patients must have received trastuzumab and progressed after 1L to be eligible for enrolment. Patients who have received an immune checkpoint inhibitor (ICI) previously will exclusively be enrolled in Arm 1 (HER-Vaxx + chemotherapy). Patients who are naïve to ICI treatment will exclusively be enrolled into Arm 2 (HER-Vaxx + pembrolizumab).

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-17
• Primary completion: 2024-04-04
• Completion: 2024-04-04
• First posted: 2022-04-05
• Last updated: 2025-05-11
• Results posted: 2025-05-11

Locations

7 sites across 2 countries: Australia, Taiwan

Regulatory

• FDA-regulated drug study