Gastric CancerPhase 2nextHERIZONNCT05311176
A Study of IMU-131 (HER-Vaxx) in Combination With Chemotherapy or Pembrolizumab in Patients With Metastatic HER2/Neu Over-Expressing Gastric Cancer (nextHERIZON)
A Phase 2 study testing IMU-131, Ramucirumab plus Paclitaxel and Pembrolizumab in people with Gastric Cancer and Cancer of Stomach, run by Imugene Limited at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Cancer of Stomach, Gastric Adenocarcinoma
- What is being tested?
- IMU-131, Ramucirumab plus Paclitaxel and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 17 Aug 2022to 4 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Taiwan5 sites
Kaohsiung Medical University Hospital
Kaohsiung City
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital, Linkou
Taoyuan City
Australia2 sites
Southern Medical Day Care Centre
Wollongong, New South Wales
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
About this study
Official title: 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
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.
Read the 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
- Being tested
- IMU-131, Ramucirumab plus Paclitaxel, Pembrolizumab
- Keywords
- HER2, Immunotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMU-131Biological
Also called HER-Vaxx
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 PaclitaxelDrug
Also called Standard of Care Chemotherapy
Chemotherapy to be administered every 3 weeks (Q3W) starting on Day 1.
PembrolizumabBiological
Also called Keytruda
Pembrolizumab will be administered every 3 weeks (Q3W) starting on Day 1 until disease progression or treatment discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: HER-Vaxx in combination with chemotherapy (ramucirumab plus paclitaxel) | Experimental | 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) Receives: Biological: IMU-131; Drug: Ramucirumab plus Paclitaxel |
| Arm 2: HER-Vaxx in combination with pembrolizumab | Experimental | 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. Receives: Biological: IMU-131; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Measured: First dose of study drug up to approximately 1.5 years
Number of Participants With Immune-related Adverse Events (irAEs)
irAEs were monitored throughout the study as per National Comprehensive Cancer Network® (NCCN) guidelines. irAEs were defined as any Grade ≥3 event that did not resolve to Grade 1 (or baseline) within 7 days from the onset of the event, or any Grade ≥3 organ toxicity involving major organ systems that persisted for greater than 72 hours.
Measured: First dose of study drug up to approximately 1.5 years
Number of Participants With Objective Response
Objective response was defined as the number of participants achieving a confirmed best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1).
- CR: Disappearance of all target lesions.
- PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to approximately 6 months
Secondary outcomes (3)
Overall Survival (OS)
Overall Survival (OS) was defined as the time from first dose of study drug to death due from any cause.
Measured: Up to approximately 6 months
Progression Free Survival (PFS)
PFS was defined as the time from first dose of study drug to first documentation of progressive disease (PD) based on RECIST 1.1, or to death from any cause.
PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: Up to approximately 6 months
Duration of Response (DoR)
DoR was measured from earliest CR or PR until first documentation of PD based on RECIST 1.1 or death due to any cause.
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start17 Aug 2022
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Why it stopped: Study was discontinued because of slow enrollment and organizational priorities and not because of any findings related to safety or efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imugene Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311176
- Sponsor's protocol ID
- IMU.131.203
- Acronym
- nextHERIZON
- Status last verified
- Feb 2024
- First submitted
- 8 Mar 2022
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05311176
- Acronym / sponsor ID
- nextHERIZON / IMU.131.203
- Conditions
- Gastric Cancer, Cancer of Stomach, Gastric Adenocarcinoma, Stomach Cancer, Stomach Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Keywords
- HER2, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was discontinued because of slow enrollment and organizational priorities and not because of any findings related to safety or efficacy.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Imugene LimitedIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Posted 11 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: HER-Vaxx in combination with chemotherapy (ramucirumab plus paclitaxel) | Experimental | Biological: IMU-131, Drug: Ramucirumab plus PaclitaxelPatients 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) |
| Arm 2: HER-Vaxx in combination with pembrolizumab | Experimental | Biological: IMU-131, Biological: PembrolizumabArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMU-131Also: HER-VaxxIMU-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. | Biological | Arm 1: HER-Vaxx in combination with chemotherapy (ramucirumab plus paclitaxel), Arm 2: HER-Vaxx in combination with pembrolizumab |
| Ramucirumab plus PaclitaxelAlso: Standard of Care ChemotherapyChemotherapy to be administered every 3 weeks (Q3W) starting on Day 1. | Drug | Arm 1: HER-Vaxx in combination with chemotherapy (ramucirumab plus paclitaxel) |
| PembrolizumabAlso: KeytrudaPembrolizumab will be administered every 3 weeks (Q3W) starting on Day 1 until disease progression or treatment discontinuation. | Biological | Arm 2: HER-Vaxx in combination with pembrolizumab |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose of study drug up to approximately 1.5 years
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Number of Participants With Immune-related Adverse Events (irAEs)
Time frame: First dose of study drug up to approximately 1.5 years
irAEs were monitored throughout the study as per National Comprehensive Cancer Network® (NCCN) guidelines. irAEs were defined as any Grade ≥3 event that did not resolve to Grade 1 (or baseline) within 7 days from the onset of the event, or any Grade ≥3 organ toxicity involving major organ systems that persisted for greater than 72 hours.
Number of Participants With Objective Response
Time frame: Up to approximately 6 months
Objective response was defined as the number of participants achieving a confirmed best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1). * CR: Disappearance of all target lesions. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
3 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 6 months
Progression Free Survival (PFS)
Time frame: Up to approximately 6 months
Duration of Response (DoR)
Time frame: Up to approximately 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Imugene LimitedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMU-131, Ramucirumab plus Paclitaxel and Pembrolizumab in people with Gastric Cancer and Cancer of Stomach, run by Imugene Limited at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.