Gastrointestinal NeoplasmsPhase 1/2NCT02795988
A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2 Positive Advanced Gastric Cancer
A Phase 1/2 study testing IMU-131 and Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine. in people with Gastrointestinal Neoplasms and Adenocarcinoma, run by Imugene Limited at 22 sites in 7 countries.
Trial summary
The Phase 1b study is an open-label, multicenter dose escalation study designed to assess the safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131. The RP2D will be evaluated in the dose expansion Phase 2 study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms, Adenocarcinoma
- What is being tested?
- IMU-131 and Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 30 Aug 2017to 20 Mar 2024
- Phase
- Phase 1/2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines;
- Age ≥ 20 years old;
- Life expectancy of at least 12 weeks;
- Phase 1b: No prior chemotherapy or radiotherapy for advanced gastric or GEJ cancer within 6 months prior to Day 0; Phase 2: No prior chemotherapy or radiotherapy for advanced gastric or GEJ cancer within 3 months prior to Day 0;
- Metastatic gastric or GEJ adenocarcinoma, or locally advanced disease not amenable to surgical resection;
- HER2/neu overexpression (3+ by immunohistochemistry (IHC) or if IHC 2+ confirmed by fluorescent in situ hybridization [FISH] or chromogenic in situ hybridization [CISH]). Patients with IHC 2+ expression without confirmation of overexpression by fluorescent in situ hybridization [FISH] or chromogenic in situ hybridization [CISH]) may be included in Phase 1b with agreement of Imugene Limited;
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- Phase 1b: ECOG performance status 0-1; Phase 2: ECOG performance status 0-2;
- At least one measurable lesion as defined by RECIST 1.1 criteria. Patients with non-measurable lesions may be included in Phase1b with agreement of Imugene Limited;
- Adequate left ventricular ejection function at baseline, defined as LVEF > 50% by echocardiogram or MUGA scan (Multi Gated Acquisition Scan);
- Adequate hematologic function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL;
- Adequate liver function evidenced by bilirubin ≤ 1.5 x laboratory upper limit of normal [ULN], and ALT and AST ≤ 3 x laboratory ULN if no liver involvement or ALT and AST ≤ 5 times laboratory ULN with liver involvement;
- Adequate renal function (creatinine ≤ 1.5 x laboratory ULN);
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment (see section 4.3 for details). A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
Who cannot join
- Previous treatment with trastuzumab or any other HER2/neu targeting antibody or agent;
- Continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease;
- Prior organ transplant;
- Phase 1b: Patient not considered a candidate for 5-FU, capecitabine, or cisplatin chemotherapy; Phase 2: Patient not considered a candidate for 5-FU, capecitabine, cisplatin or oxaliplatin chemotherapy;
- History of documented congestive heart failure; angina pectoris requiring antianginal medication; evidence of transmural infarction on ECG; poorly controlled hypertension; clinically significant valvular heart disease; high risk uncontrolled arrhythmias; or New York Heart Association (NYHA) class II heart disease;
- If on warfarin (Coumadin®) or other vitamin K antagonists;
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- Concurrent active malignancy except for adequately controlled limited basal cell carcinoma of the skin;
- Peripheral neuropathy or hearing loss of NCI CTCAE Grade > 2;
- History of uncontrolled seizures, central nervous disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent, participation in the study, or adversely affecting compliance to study drugs;
- Active infection requiring IV antibiotics;
- Positive 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;
- Pregnant or lactating females;
- Major surgery within 4 weeks prior to study entry. Minor surgery (excluding diagnostic biopsy) within 1 week prior to study entry;
- Has received a live-virus vaccination within 4 weeks of first study vaccination. Seasonal flu vaccines that do not contain live virus are permitted;
- Current or recent (within 4 weeks of first IMU-131 vaccination) treatment with another investigational drug or participation in another investigational study.
- Phase 2: Patients with a known diphtheria toxoid hypersensitivity.
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
India10 sites
Victoria Hospital
Bangalore, 560002
Shetty's Hospital
Bengaluru, Karnataka, 560068
North East Cancer Hospital and Research Institute
Guwahati, Assam, 781023
MNJ Institute of Oncology and Regional Cancer Centre
Hyderabad, 500004
Tata Medical Centre
Kolkata, 700160
HCG NCHRI Cancer Centre
Nagpur, 440026
Curie Manavata Cancer Centre
Nashik, Maharashtra, 422004
Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
Patna, 800014
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004
City Cancer Center
Vijayawada, Andhra Pradesh, 520002
Serbia4 sites
Institute for Oncology and Radiology of Serbia - PPDS
Belgrade, 11000
Military Medical Academy
Belgrade, 11000
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11070
Oncology Institute of Vojvodina
Kamenitz, Južnobanatski Okrug, 21204
Thailand3 sites
National Cancer Institute of Thailand
Bangkok, 10400
Division of Oncology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University
Chiang Mai, 50200
Division of Medical Oncology, Department of Medicine, Prince of Songkla University, Songklanagarind Hospital
Hat Yai, Changwat Songkhla, 90110
Taiwan2 sites
National Cheng-Kung University Hospital
Tainan, 70403
Taipei Veterans General Hospital
Taipei, 11217
Moldova1 site
ARENSIA Exploratory Medicine IMSP Institutul Oncologic
Chisinau, 2025
About this study
Official title: A Phase 1b/2 Open-Label Study With Randomization in Phase 2 of IMU-131 HER2/Neu Peptide Vaccine Plus Standard of Care Chemotherapy in Patients With HER2/Neu Overexpressing Metastatic or Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction
The Phase 1b study is an open-label, multicenter dose escalation study designed to assess the safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131. The RP2D will be evaluated in the dose expansion Phase 2 study. The Phase 2 study is a randomized, open label comparison of IMU-131 plus standard of care chemotherapy versus standard of care chemotherapy alone.
- Conditions
- Gastrointestinal Neoplasms, Adenocarcinoma
- Being tested
- IMU-131, Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.
- Keywords
- Secondary
- Medical subject headings
- Gastrointestinal Neoplasms, Adenocarcinoma, Neoplasm Metastasis
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 vaccine is a P467-CRM197 peptide antigen in PBS buffer and Montanide ISA 51 Sterile adjuvant
Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.Drug
Also called Standard of Care Chemotherapy
Chemotherapy will consist of: cisplatin by intravenous administration at 80 mg/m2 on the first day of each cycle and either 5-FU, 4000 mg/m2 CIV (administered as 1000 mg/m2/day as continuous infusion for 96 hours on days 1 to 4 of each cycle) or capecitabine for 14 days at 2000 mg/m2/day, orally (administered as 1000 mg/m2 twice daily morning and evening for a total of 2000 mg/m2/day on days 1 to 14 of each cycle), or (in Phase 2 only) oxaliplatin, by intravenous administration at 130 mg/m2 on Day 1 of each cycle and capecitabine for 14 days at 2000 mg/m2/day, orally (administered as 1000 mg/m2 twice daily morning and evening for a total of 2000 mg/m2/day on days 1 to 14 of each cycle).
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b | Experimental | 10, 30, 50μg IMU-131 plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine Receives: Biological: IMU-131; Drug: Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine. |
| Phase 2 - IMU 131 plus chemotherapy | Experimental | 50 μg IMU-131 plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and Capecitabine. Receives: Biological: IMU-131; Drug: Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine. |
| Phase 2 - Chemotherapy only | Experimental | Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and Capecitabine. Receives: Drug: Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Number of Participants With Adverse Events (AEs)
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: Up to approximately 7 months
Phase 2: Overall Survival (OS)
OS was measured from date of randomization to date of death due to any cause.
Measured: Up to approximately 30 months
Phase 2 Extension: Number of Participants With AEs
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: From date of first dose to date of last dose plus 30 days (Up to 24 months)
Secondary outcomes (7)
Phase 2 and Phase 2 Extension: Progression-Free Survival (PFS)
PFS was measured from randomization to date of earliest progressive disease (PD) based on blinded central review according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or to date of death from any cause.
Measured: Up to approximately 30 months
Phase 2 and Phase 2 Extension: Time to Progression (TTP)
TTP was measured from randomization to date of earliest PD based on blinded central review according to RECIST 1.1 criteria.
Measured: Up to approximately 30 months
Phase 2 and Phase 2 Extension: Disease Control Rate (DCR)
DCR was defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or stable disease according to RECIST 1.1 after randomization/enrollment date.
Measured: Up to approximately 30 months
Phase 2 and Phase 2 Extension: Objective Response Rate (ORR)
ORR was defined as the proportion of participants with a BOR of CR or PR according RECIST 1.1 after randomization/enrollment date.
Measured: Up to approximately 30 months
Phase 2 and Phase 2 Extension: Duration of Response (DOR)
DOR was defined as the time from the earliest date when a tumor response of CR or PR was observed until the date of first occurrence of disease progression which assessed by the blinded central reviewer or death (due to any reason).
Measured: Up to approximately 30 months
Phase 2 and Phase 2 Extension: Percentage Change From Baseline in Tumor Size
Change in tumor size (CTS) was measured as the sum of diameters based on blinded central review according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).
Measured: Baseline up to approximately 30 months
Phase 2 Extension: OS
OS was measured from date of randomization to date of death due to any cause.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start30 Aug 2017
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 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
- NCT02795988
- Sponsor's protocol ID
- IMU.ACS.001
- Status last verified
- Mar 2025
- First submitted
- 1 Jun 2016
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tobias J, Maglakelidze M, Andric Z, Ryspayeva D, Bulat I, Nikolic I, Petrovic Z, Chawla T, Nagarkar R, Garner-Spitzer E, Zielinski CC, Chong LMO, Nixon B, Ede NJ, Yavrom S, Kundi M, Wiedermann U. Phase II Trial of HER-Vaxx, a B-cell Peptide-Based Vaccine, in HER2-Overexpressing Advanced Gastric Cancer Patients Under Platinum-Based Chemotherapy (HERIZON). Clin Cancer Res. 2024 Sep 13;30(18):4044-4054. doi: 10.1158/1078-0432.CCR-24-0742.
PubMed 39028916Wiedermann U, Garner-Spitzer E, Chao Y, Maglakelidze M, Bulat I, Dechaphunkul A, Arpornwirat W, Charoentum C, Yen CJ, Yau TC, Tanasanvimon S, Maneechavakajorn J, Sookprasert A, Bai LY, Chou WC, Ungtrakul T, Drinic M, Tobias J, Zielinski CC, Chong L, Ede NJ, Marino MT, Good AJ. Clinical and Immunologic Responses to a B-Cell Epitope Vaccine in Patients with HER2/neu-Overexpressing Advanced Gastric Cancer-Results from Phase Ib Trial IMU.ACS.001. Clin Cancer Res. 2021 Jul 1;27(13):3649-3660. doi: 10.1158/1078-0432.CCR-20-3742. Epub 2021 Apr 20.
PubMed 33879458
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Open-Label Study With Randomization in Phase 2 of IMU-131 HER2/Neu Peptide Vaccine Plus Standard of Care Chemotherapy in Patients With HER2/Neu Overexpressing Metastatic or Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction
- ClinicalTrials.gov ID
- NCT02795988
- Acronym / sponsor ID
- IMU.ACS.001
- Conditions
- Gastrointestinal Neoplasms, Adenocarcinoma
- Keywords
- Secondary
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Imugene LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Phase 1b study is an open-label, multicenter dose escalation study designed to assess the safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131. The RP2D will be evaluated in the dose expansion Phase 2 study. The Phase 2 study is a randomized, open label comparison of IMU-131 plus standard of care chemotherapy versus standard of care chemotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1b | Experimental | Biological: IMU-131, Drug: Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.10, 30, 50μg IMU-131 plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine |
| Phase 2 - IMU 131 plus chemotherapy | Experimental | Biological: IMU-131, Drug: Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.50 μg IMU-131 plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and Capecitabine. |
| Phase 2 - Chemotherapy only | Experimental | Drug: Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and Capecitabine. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines;
- Age ≥ 20 years old;
- Life expectancy of at least 12 weeks;
- Phase 1b: No prior chemotherapy or radiotherapy for advanced gastric or GEJ cancer within 6 months prior to Day 0; Phase 2: No prior chemotherapy or radiotherapy for advanced gastric or GEJ cancer within 3 months prior to Day 0;
- Metastatic gastric or GEJ adenocarcinoma, or locally advanced disease not amenable to surgical resection;
Key exclusion criteria (16 listed)
- Previous treatment with trastuzumab or any other HER2/neu targeting antibody or agent;
- Continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease;
- Prior organ transplant;
- Phase 1b: Patient not considered a candidate for 5-FU, capecitabine, or cisplatin chemotherapy; Phase 2: Patient not considered a candidate for 5-FU, capecitabine, cisplatin or oxaliplatin chemotherapy;
- History of documented congestive heart failure; angina pectoris requiring antianginal medication; evidence of transmural infarction on ECG; poorly controlled hypertension; clinically significant valvular heart disease; high risk uncontrolled arrhythmias; or New York Heart Association (NYHA) class II heart disease;
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 vaccine is a P467-CRM197 peptide antigen in PBS buffer and Montanide ISA 51 Sterile adjuvant | Biological | Phase 1b, Phase 2 - IMU 131 plus chemotherapy |
| Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.Also: Standard of Care ChemotherapyChemotherapy will consist of: cisplatin by intravenous administration at 80 mg/m2 on the first day of each cycle and either 5-FU, 4000 mg/m2 CIV (administered as 1000 mg/m2/day as continuous infusion for 96 hours on days 1 to 4 of each cycle) or capecitabine for 14 days at 2000 mg/m2/day, orally (administered as 1000 mg/m2 twice daily morning and evening for a total of 2000 mg/m2/day on days 1 to 14 of each cycle), or (in Phase 2 only) oxaliplatin, by intravenous administration at 130 mg/m2 on Day 1 of each cycle and capecitabine for 14 days at 2000 mg/m2/day, orally (administered as 1000 mg/m2 twice daily morning and evening for a total of 2000 mg/m2/day on days 1 to 14 of each cycle). | Drug | Phase 1b, Phase 2 - Chemotherapy only, Phase 2 - IMU 131 plus chemotherapy |
Primary outcome
Phase 1b: Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 7 months
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.
Phase 2: Overall Survival (OS)
Time frame: Up to approximately 30 months
OS was measured from date of randomization to date of death due to any cause.
Phase 2 Extension: Number of Participants With AEs
Time frame: From date of first dose to date of last dose plus 30 days (Up to 24 months)
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.
7 secondary outcomes
Phase 2 and Phase 2 Extension: Progression-Free Survival (PFS)
Time frame: Up to approximately 30 months
Phase 2 and Phase 2 Extension: Time to Progression (TTP)
Time frame: Up to approximately 30 months
Phase 2 and Phase 2 Extension: Disease Control Rate (DCR)
Time frame: Up to approximately 30 months
Phase 2 and Phase 2 Extension: Objective Response Rate (ORR)
Time frame: Up to approximately 30 months
Phase 2 and Phase 2 Extension: Duration of Response (DOR)
Time frame: Up to approximately 30 months
Phase 2 and Phase 2 Extension: Percentage Change From Baseline in Tumor Size
Time frame: Baseline up to approximately 30 months
Phase 2 Extension: OS
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39028916Tobias J, Maglakelidze M, Andric Z, Ryspayeva D, Bulat I, Nikolic I, Petrovic Z, Chawla T, Nagarkar R, Garner-Spitzer E, Zielinski CC, Chong LMO, Nixon B, Ede NJ, Yavrom S, Kundi M, Wiedermann U. Phase II Trial of HER-Vaxx, a B-cell Peptide-Based Vaccine, in HER2-Overexpressing Advanced Gastric Cancer Patients Under Platinum-Based Chemotherapy (HERIZON). Clin Cancer Res. 2024 Sep 13;30(18):4044-4054. doi: 10.1158/1078-0432.CCR-24-0742.
- Derived from this study: PubMed 33879458Wiedermann U, Garner-Spitzer E, Chao Y, Maglakelidze M, Bulat I, Dechaphunkul A, Arpornwirat W, Charoentum C, Yen CJ, Yau TC, Tanasanvimon S, Maneechavakajorn J, Sookprasert A, Bai LY, Chou WC, Ungtrakul T, Drinic M, Tobias J, Zielinski CC, Chong L, Ede NJ, Marino MT, Good AJ. Clinical and Immunologic Responses to a B-Cell Epitope Vaccine in Patients with HER2/neu-Overexpressing Advanced Gastric Cancer-Results from Phase Ib Trial IMU.ACS.001. Clin Cancer Res. 2021 Jul 1;27(13):3649-3660. doi: 10.1158/1078-0432.CCR-20-3742. Epub 2021 Apr 20.
- Imugene (ASX: IMU) is a publicly-listed biotechnology company.Link 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.
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMU-131 and Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine. in people with Gastrointestinal Neoplasms and Adenocarcinoma, run by Imugene Limited at 22 sites in 7 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 14 inclusion and 16 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: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in India, Serbia, Thailand, Taiwan, Georgia and 2 more countries. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 16 Apr 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?
Phase 1b: Number of Participants With Adverse Events (AEs) (time frame: Up to approximately 7 months). 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?
On the ClinicalTrials.gov record for NCT02795988, which also lists 2 linked publications.
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 16 Apr 2025.