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Study to Evaluate Safety & Tolerability of AGI-134 in Solid Tumour
Phase 1, PHASE2 trial testing AGI-134 in Superficial, Palpable, Unresectable/Metastatic Solid Tumour in 38 participants. Completed in 31 December 2023.
| Lead sponsor | Agalimmune Ltd. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 30 November 2018 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 14 locations across United Kingdom, United States, Israel |
Agalimmune Ltd.
18 and older, any sex, with Superficial, Palpable, Unresectable/Metastatic Solid Tumour. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Safety and tolerability of AGI-134 injected intra-tumourally (IT) by assessment of the percentage of participants who experienced a dose-limiting toxicity (DLT) . DLTs will be assessed during the first cycle (21 days)
| Group | Value | 95% CI |
|---|---|---|
| AGI-134 25 mg | 0 | |
| AGI-134 50 mg | 0 | |
| AGI-134 100 mg | 0 | |
| AGI-134 200 mg | 0 |
Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event (AE) AEs are defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment, is also an AE. The
| Group | Value | 95% CI |
|---|---|---|
| AGI-134 25mg/1mL | 0 | |
| AGI-134 50mg/2mL | 1 | |
| AGI-134 100mg/4mL | 0 | |
| AGI-134 200mg/8mL | 0 |
Time frame: AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Overall | AGI-134 25 mg | AGI-134 50 mg | AGI-134 100 mg | AGI-134 200 mg |
|---|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — |
| Bradycardia | Cardiac disorders | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — |
| Syncope | Nervous system disorders | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — |
| Catheter site infection | Infections and infestations | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — |
| Chills | General disorders | — | — | — | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Groin infection | Infections and infestations | — | — | — | — | — |
| Injection related reaction | Injury, poisoning and procedural complications | — | — | — | — | — |
| Skin infection | Infections and infestations | — | — | — | — | — |
| Lower respiratory tract infection | Infections and infestations | — | — | — | — | — |
| Localised infection | Infections and infestations | — | — | — | — | — |
| Injection site infection | Infections and infestations | — | — | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — | — | — |
| Oliguria | Renal and urinary disorders | — | — | — | — | — |
| Pelvic pain | Reproductive system and breast disorders | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — |
| Pericardial effusion | Cardiac disorders | — | — | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Hypersensitivity | Immune system disorders | — | — | — | — | — |
| Confusional state | Psychiatric disorders | — | — | — | — | — |
| Reaction | System | Overall | AGI-134 25 mg | AGI-134 50 mg | AGI-134 100 mg | AGI-134 200 mg |
|---|---|---|---|---|---|---|
| Fatigue | General disorders | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — |
| Injection site pain | General disorders | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Lymphopenia | Blood and lymphatic system disorders | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — |
| Chest discomfort | General disorders | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — |
| Blood lactate dehydrogenase increased | Investigations | — | — | — | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Tachycardia | Cardiac disorders | — | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — | — |
| Chills | General disorders | — | — | — | — | — |
| Cellulitis | Infections and infestations | — | — | — | — | — |
| Presyncope | Nervous system disorders | — | — | — | — | — |
| Paraesthesia | Nervous system disorders | — | — | — | — | — |
| Flushing | Vascular disorders | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — |
| Lymph node pain | Blood and lymphatic system disorders | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — |
| Asthenia | General disorders | — | — | — | — | — |
| Peripheral swelling | General disorders | — | — | — | — | — |
| Injection site discomfort | General disorders | — | — | — | — | — |
| Injection site erythema | General disorders | — | — | — | — | — |
| Nodule | General disorders | — | — | — | — | — |
Most-reported serious reactions: Abdominal pain, Bradycardia, Hypotension, Syncope, Anaemia, Pyrexia, Catheter site infection, Nausea.
Data from ClinicalTrials.gov NCT03593226 adverse events section.
This study will evaluate if AGI-134 given alone is safe and tolerate in treating patients with unresectable/metastatic solid tumours.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03593226.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing