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

Sponsor
Imugene Limited
Study ID
NCT05311176
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • IMU-131 — BIOLOGICAL
    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.
  • Ramucirumab plus Paclitaxel — DRUG
    Chemotherapy to be administered every 3 weeks (Q3W) starting on Day 1.
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab will be administered every 3 weeks (Q3W) starting on Day 1 until disease progression or treatment discontinuation.

Study Details

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.

Key Dates

Start date
Aug 17, 2022
Status verified
Feb 2024
Primary completion
Apr 4, 2024
Completion
Apr 4, 2024

Study Design

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

Arms

  • Experimental: Arm 1: HER-Vaxx in combination with chemotherapy (ramucirumab plus paclitaxel)
    Patients who have received an immune checkpoint inhibitor (ICI) previously will exclusively be enrolled in Arm 1 treated with HER-Vaxx (IM) in combination with chemotherapy (ramucirumab plus paclitaxel)
  • Experimental: Arm 2: HER-Vaxx in combination with pembrolizumab
    Arm 2 will investigate the combination of HER-Vaxx plus pembrolizumab in patients who are naïve to ICI treatment including patients who have had chemotherapy only treatment after progression on trastuzumab. As the combination treatment has not been investigated, Arm 2 is planned to initiate with a safety run-in phase.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose of study drug up to approximately 1.5 years ]

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