NCT02795988

A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2 Positive Advanced Gastric Cancer

Completed Phase 1, PHASE2 Results posted Last updated 16 April 2025

What this trial tests

Phase 1, PHASE2 trial testing IMU-131 in Gastrointestinal Neoplasms in 64 participants. Completed in 20 March 2024.

Timeline

30 August 2017

Primary endpoint
20 March 2024

20 March 2024

Quick facts

Lead sponsor	Imugene Limited
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	64
Start date	30 August 2017
Primary completion	20 March 2024
Estimated completion	20 March 2024
Sites	22 locations across Georgia, Ukraine, Serbia, Taiwan, Moldova, Thailand, India

Drugs / interventions tested

• IMU-131 — full drug profile →
• Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine. — full drug profile →

Conditions studied

• Gastrointestinal Neoplasms — all drugs for Gastrointestinal Neoplasms →
• Adenocarcinoma — all drugs for Adenocarcinoma →

Sponsor

Imugene Limited — full company profile →

Who can join

20 and older, any sex, with Gastrointestinal Neoplasms or Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phase 1b: Number of Participants With Adverse Events (AEs) Primary · 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.

Group	Value	95% CI
Phase 1b: 10 μg IMU-131 Plus Chemotherapy	3
Phase 1b: 30 μg IMU-131 Plus Chemotherapy	6
Phase 1b: 50 μg IMU-131 Plus Chemotherapy	5

Phase 2: Overall Survival (OS) Primary · Up to approximately 30 months

OS was measured from date of randomization to date of death due to any cause.

Group	Value	95% CI
Phase 2: IMU-131 Plus Chemotherapy	13.90	7.52 – 14.32
Phase 2: Chemotherapy Only	8.31	6.01 – 9.59

Phase 2 Extension: Number of Participants With AEs Primary · 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.

Group	Value	95% CI
Phase 2 Extension: IMU-131 100 μg	7
Phase 2 Extension: IMU-131 200 μg	5

Phase 2 and Phase 2 Extension: Progression-Free Survival (PFS) Secondary · Up to approximately 30 months

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.

Group	Value	95% CI
Phase 2: IMU-131 Plus Chemotherapy	6.93	5.59 – 9.86
Phase 2: Chemotherapy Only	6.01	2.17 – 8.31
Phase 2 Extension: IMU-131 100 μg	5.03	1.38 – 9.89
Phase 2 Extension: IMU-131 200 μg	8.34	5.52 – 8.34

Phase 2 and Phase 2 Extension: Time to Progression (TTP) Secondary · Up to approximately 30 months

TTP was measured from randomization to date of earliest PD based on blinded central review according to RECIST 1.1 criteria.

Group	Value	95% CI
Phase 2: IMU-131 Plus Chemotherapy	6.93	5.59 – 9.86
Phase 2: Chemotherapy Only	8.44	8.44 – NA
Phase 2 Extension: IMU-131 100 μg	5	4.1 – 8.9
Phase 2 Extension: IMU-131 200 μg	5.5	3.5 – 7.5

Phase 2 and Phase 2 Extension: Disease Control Rate (DCR) Secondary · Up to approximately 30 months

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.

Group	Value	95% CI
Phase 2: IMU-131 Plus Chemotherapy	77.8	63.20 – 87.70
Phase 2: Chemotherapy Only	71.4	54.40 – 84.00
Phase 2 Extension: IMU-131 100 μg	71.4	47.20 – 87.50
Phase 2 Extension: IMU-131 200 μg	85.7	62.20 – 95.60

Phase 2 and Phase 2 Extension: Objective Response Rate (ORR) Secondary · Up to approximately 30 months

ORR was defined as the proportion of participants with a BOR of CR or PR according RECIST 1.1 after randomization/enrollment date.

Group	Value	95% CI
Phase 2: IMU-131 Plus Chemotherapy	38.9	25.70 – 53.90
Phase 2: Chemotherapy Only	50.0	33.80 – 66.20
Phase 2 Extension: IMU-131 100 μg	42.9	22.60 – 65.80
Phase 2 Extension: IMU-131 200 μg	71.4	47.20 – 87.50

Phase 2 and Phase 2 Extension: Duration of Response (DOR) Secondary · Up to approximately 30 months

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).

Group	Value	95% CI
Phase 2: IMU-131 Plus Chemotherapy	7.10	2.79 – NA
Phase 2: Chemotherapy Only	4.40	4.07 – NA
Phase 2 Extension: IMU-131 100 μg	3.65	2.92 – NA
Phase 2 Extension: IMU-131 200 μg	5.59	1.12 – 5.59

Phase 2 and Phase 2 Extension: Percentage Change From Baseline in Tumor Size Secondary · Baseline up to approximately 30 months

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).

Group	Value	95% CI
Phase 2: IMU-131 Plus Chemotherapy	-22.4	-39.4 – -19.7
Phase 2: Chemotherapy Only	-34.4	-34.6 – -16.9
Phase 2 Extension: IMU-131 100 μg	-43.1	-53.7 – -38.0
Phase 2 Extension: IMU-131 200 μg	-36.8	-47.7 – -32.2

Phase 2 Extension: OS Secondary · Up to 24 months

OS was measured from date of randomization to date of death due to any cause.

Group	Value	95% CI
Phase 2 Extension: IMU-131 100 μg	18.27	5.03 – 19.84
Phase 2 Extension: IMU-131 200 μg	9.36	4.40 – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 30 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1b: 10 μg IMU-131 Plus Chemotherapy

Serious: 2/3 (67%)

Deaths: 1/3

Phase 1b: 30 μg IMU-131 Plus Chemotherapy

Serious: 4/6 (67%)

Deaths: 2/6

Phase 1b: 50 μg IMU-131 Plus Chemotherapy

Serious: 3/5 (60%)

Deaths: 1/5

Phase 2: IMU-131 Plus Chemotherapy

Serious: 2/19 (11%)

Deaths: 17/19

Phase 2: Chemotherapy Only

Serious: 5/17 (29%)

Deaths: 17/17

Phase 2 Extension: IMU-131 100 μg

Serious: 0/7 (0%)

Deaths: 5/7

Phase 2 Extension: IMU-131 200 μg

Serious: 2/7 (29%)

Deaths: 6/7

Serious adverse events (23 terms)

Reaction	System	Phase 1b: 10 μg IMU-131 Pl…	Phase 1b: 30 μg IMU-131 Pl…	Phase 1b: 50 μg IMU-131 Pl…	Phase 2: IMU-131 Plus Chem…	Phase 2: Chemotherapy Only	Phase 2 Extension: IMU-131…	Phase 2 Extension: IMU-131…
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Inappropriate antidiuretic hormone secretion	Endocrine disorders	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Malnutrition	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—	—	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Acute hepatic failure	Hepatobiliary disorders	—	—	—	—	—	—	—
Jaundice cholestatic	Hepatobiliary disorders	—	—	—	—	—	—	—
Corona virus infection	Infections and infestations	—	—	—	—	—	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Gastrointestinal toxicity	Gastrointestinal disorders	—	—	—	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—
Electrocardiogram abnormal	Investigations	—	—	—	—	—	—	—
Ischaemic stroke	Nervous system disorders	—	—	—	—	—	—	—
Laryngospasm	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—

Other adverse events (138 terms — click to expand)

Reaction	System	Phase 1b: 10 μg IMU-131 Pl…	Phase 1b: 30 μg IMU-131 Pl…	Phase 1b: 50 μg IMU-131 Pl…	Phase 2: IMU-131 Plus Chem…	Phase 2: Chemotherapy Only	Phase 2 Extension: IMU-131…	Phase 2 Extension: IMU-131…
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Hydronephrosis	Renal and urinary disorders	—	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Injection site reaction	General disorders	—	—	—	—	—	—	—
Peripheral swelling	General disorders	—	—	—	—	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—	—	—	—	—
Neuropathy peripheral	Nervous system disorders	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Anaemia folate deficiency	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Haemorrhagic anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—	—	—	—	—
Dry eye	Eye disorders	—	—	—	—	—	—	—
Eye swelling	Eye disorders	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—
Aphthous ulcer	Gastrointestinal disorders	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—
Gastrointestinal ulcer	Gastrointestinal disorders	—	—	—	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—	—	—	—

Most-reported serious reactions: Acute kidney injury, Anaemia, Febrile neutropenia, Leukocytosis, Neutropenia, Inappropriate antidiuretic hormone secretion, Gastritis, Pneumonia.

Data from ClinicalTrials.gov NCT02795988 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer vaccines as promising immuno-therapeutics: platforms and current progress.
   Liu J, Fu M, Wang M, Wan D, et al · · 2022 · cited 497× · PMID 35303904 · DOI 10.1186/s13045-022-01247-x
2. Trial watch: chemotherapy-induced immunogenic cell death in immuno-oncology.
   Vanmeerbeek I, Sprooten J, De Ruysscher D, Tejpar S, et al · · 2020 · cited 179× · PMID 32002302 · DOI 10.1080/2162402x.2019.1703449
3. Trial watch: Peptide-based vaccines in anticancer therapy.
   Bezu L, Kepp O, Cerrato G, Pol J, et al · · 2018 · cited 114× · PMID 30524907 · DOI 10.1080/2162402x.2018.1511506
4. Beyond Just Peptide Antigens: The Complex World of Peptide-Based Cancer Vaccines.
   Stephens AJ, Burgess-Brown NA, Jiang S. · · 2021 · cited 112× · PMID 34276688 · DOI 10.3389/fimmu.2021.696791
5. Precision medicine in gastric cancer.
   Bonelli P, Borrelli A, Tuccillo FM, Silvestro L, et al · · 2019 · cited 68× · PMID 31662821 · DOI 10.4251/wjgo.v11.i10.804
6. Therapeutic cancer vaccines: From biological mechanisms and engineering to ongoing clinical trials.
   Sobhani N, Scaggiante B, Morris R, Chai D, et al · · 2022 · cited 57× · PMID 35759856 · DOI 10.1016/j.ctrv.2022.102429
7. Immunotherapy in Gastrointestinal Cancers.
   Procaccio L, Schirripa M, Fassan M, Vecchione L, et al · · 2017 · cited 54× · PMID 28758114 · DOI 10.1155/2017/4346576
8. Turbocharging vaccines: emerging adjuvants for dendritic cell based therapeutic cancer vaccines.
   Saxena M, Bhardwaj N. · · 2017 · cited 50× · PMID 28732279 · DOI 10.1016/j.coi.2017.06.003