Status:
TERMINATED
A Study of IMU-131 (HER-Vaxx) in Combination With Chemotherapy or Pembrolizumab in Patients With Metastatic HER2/Neu Over-Expressing Gastric Cancer (nextHERIZON)
Lead Sponsor:
Imugene Limited
Conditions:
Gastric Cancer
Cancer of Stomach
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 che...
Eligibility Criteria
Inclusion
- Age ≥ 18 years with confirmed diagnosis of advanced or metastatic HER2/neu overexpressing gastric or GEJ adenocarcinoma;
- Progressed on or after trastuzumab therapy;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Life expectancy of a minimum of 3 months;
- At least one measurable lesion as defined by RECIST 1.1 criteria and assessed by the local investigator;
- HER2/neu overexpression assessed using post-progression fresh or archival tissue, or post-progression pathology report;
- Adequate left ventricular ejection function at baseline, defined as left ventricular ejection fraction (LVEF) \> 50% by echocardiogram or Multi Gated Acquisition (MUGA) scan;
- Adequate hematologic, liver and renal function;
- A female patient of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 120 days after the last dose of assigned treatment.
Exclusion
- Previous malignant disease (other than primary malignancy) within the last 5 years, except basal or squamous cell carcinoma of the skin or cervical carcinoma in situ;
- Concurrent active malignancy except for adequately controlled limited basal cell carcinoma of the skin;
- Systemic chemotherapy or major surgery within 28 days before starting study treatment and recovered from all adverse events ≤ Grade 1 or baseline with possible exceptions for neuropathy and endocrine-related AEs;
- Received prior radiotherapy within 2 weeks of start of study treatment and recovered from all radiation-related toxicities and not require corticosteroids; or history of radiation pneumonitis.
- Previous treatment with trastuzumab-deruxtecan or any other anti-HER2 therapy (except trastuzumab);
- Clinically significant cardiovascular disease, or other diseases that in the Investigator's opinion may influence the patient's tolerance to study treatment;
- Pleural effusion or ascites requiring more than weekly drainage;
- Prior organ transplantation, including allogenic stem-cell transplantation;
- Chronic immunosuppressive therapy within 7 days prior the first dose of study drug;
- Active, known, or suspected autoimmune disease;
- History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease;
- Positivity for human immunodeficiency virus (HIV) (HIV 1/2 antibodies) or active hepatitis B (HBsAg reactive) or active hepatitis C (HCV ribonucleic acid \[RNA\] qualitative) infection;
- Current participation or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment;
- Any vaccination within 30 days prior to starting study treatment;
- Pregnant or lactating females;
- Arm 2 only: Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent;
- Arm 2 only: Has received prior therapy with an ICI or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from treatment due to a grade 3 or higher adverse event.
Key Trial Info
Start Date :
August 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05311176
Start Date
August 17 2022
End Date
April 4 2024
Last Update
May 11 2025
Active Locations (7)
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1
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
2
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
3
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
4
National Cheng Kung University Hospital
Tainan, Taiwan