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A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients (MATINS)
Phase 1, PHASE2 trial testing FP-1305 (bexmarilimab) in Cancer in 216 participants. Completed in 31 October 2023.
| Lead sponsor | Faron Pharmaceuticals Ltd |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 216 |
| Start date | 3 December 2018 |
| Primary completion | 6 September 2023 |
| Estimated completion | 31 October 2023 |
| Sites | 11 locations across France, Finland, Netherlands, United Kingdom, United States, Spain |
Faron Pharmaceuticals Ltd — full company profile →
18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Tolerable dose(s) will be determined by the TITE-CRM based on the occurrence/non-occurrence of dose limiting toxicities in the trial subjects.
| Group | Value | 95% CI |
|---|---|---|
| FP-1305 (Bexmarilimab) 0.3 mg/kg | 0 | |
| FP-1305 (Bexmarilimab) 1 mg/kg | 0 | |
| FP-1305 (Bexmarilimab) 3 mg/kg | 0 | |
| FP-1305 (Bexmarilimab) 10 mg/kg | 0 | |
| FP-1305 (Bexmarilimab) 0.1 mg/kg | 0 | |
| FP-1305 (Bexmarilimab) 30 mg/kg | 0 |
Number of adverse events and serious adverse events. Adverse events are collected, graded and reported according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
| Group | Value | 95% CI |
|---|---|---|
| FP-1305 (Bexmarilimab) 0.3 mg/kg | 13 | |
| FP-1305 (Bexmarilimab) 1 mg/kg | 122 | |
| FP-1305 (Bexmarilimab) 3 mg/kg | 38 | |
| FP-1305 (Bexmarilimab) 10 mg/kg | 17 | |
| FP-1305 (Bexmarilimab) 0.1 mg/kg | 5 | |
| FP-1305 (Bexmarilimab) 30 mg/kg | 9 |
The objective response rate (ORR) to the treatment will be determined by tumour imaging (tumor size) according to RECIST v.1.1. Results from each tumour type, dose level and dosing frequency are reported separately.
| Group | Value | 95% CI |
|---|---|---|
| FP-1305 (Bexmarilimab) 0.3 mg/kg | 1 | |
| FP-1305 (Bexmarilimab) 1 mg/kg | 0 | |
| FP-1305 (Bexmarilimab) 3 mg/kg | 0 | |
| FP-1305 (Bexmarilimab) 10 mg/kg | 0 | |
| FP-1305 (Bexmarilimab) 0.1 mg/kg | 0 | |
| FP-1305 (Bexmarilimab) 30 mg/kg | 0 |
The disease control rate (DCR) response to the treatment will be determined by tumour imaging (tumor size) according to RECIST v.1.1 are presented by cycles and by doing so there is no difference in the definition of DCR and Clinical Benefit Rate (CBR)
| Group | Value | 95% CI |
|---|---|---|
| FP-1305 (Bexmarilimab) 0.3 mg/kg | 1 | |
| FP-1305 (Bexmarilimab) 1 mg/kg | 20 | |
| FP-1305 (Bexmarilimab) 3 mg/kg | 4 | |
| FP-1305 (Bexmarilimab) 10 mg/kg | 2 | |
| FP-1305 (Bexmarilimab) 0.1 mg/kg | 0 | |
| FP-1305 (Bexmarilimab) 30 mg/kg | 1 |
Time frame: Approximately 4 years and 11 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | FP-1305 (Bexmarilimab) 0.3… | FP-1305 (Bexmarilimab) 1 m… | FP-1305 (Bexmarilimab) 3 m… | FP-1305 (Bexmarilimab) 10 … | FP-1305 (Bexmarilimab) 0.1… | FP-1305 (Bexmarilimab) 30 … |
|---|---|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — |
| Death | General disorders | — | — | — | — | — | — |
| Transaminases increased | Investigations | — | — | — | — | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — | — |
| Ileus | Gastrointestinal disorders | — | — | — | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — |
| General physical health deterioration | General disorders | — | — | — | — | — | — |
| Cholestasis | Hepatobiliary disorders | — | — | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Pancytopenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — | — | — |
| Cardiac tamponade | Cardiac disorders | — | — | — | — | — | — |
| Myocardial infarction | Cardiac disorders | — | — | — | — | — | — |
| Adrenocortical insufficiency acute | Endocrine disorders | — | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — | — | — | — |
| Reaction | System | FP-1305 (Bexmarilimab) 0.3… | FP-1305 (Bexmarilimab) 1 m… | FP-1305 (Bexmarilimab) 3 m… | FP-1305 (Bexmarilimab) 10 … | FP-1305 (Bexmarilimab) 0.1… | FP-1305 (Bexmarilimab) 30 … |
|---|---|---|---|---|---|---|---|
| General disorders and administration site conditions | General disorders | — | — | — | — | — | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — | — | — | — | — | — |
| Investigations | Investigations | — | — | — | — | — | — |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Infections and infestations | Infections and infestations | — | — | — | — | — | — |
| Nervous system disorders | Nervous system disorders | — | — | — | — | — | — |
| Vascular disorders | Vascular disorders | — | — | — | — | — | — |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Hepatobiliary disorders | Hepatobiliary disorders | — | — | — | — | — | — |
| Renal and urinary disorders | Renal and urinary disorders | — | — | — | — | — | — |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Endocrine disorders | Endocrine disorders | — | — | — | — | — | — |
| Cardiac disorders | Cardiac disorders | — | — | — | — | — | — |
Most-reported serious reactions: Ascites, Abdominal pain, Pleural effusion, Vomiting, Death, Transaminases increased, Intestinal obstruction, Constipation.
Data from ClinicalTrials.gov NCT03733990 adverse events section.
This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1. CLEVER-1 has been shown to support tumour growth. No significant adverse events were witnessed in primates and the dose used will be 300 fold lower than the dose provided to primates which showed no toxicity. The patients with advanced melanoma, uveal melanoma, cholangiocarcinoma, gallbladder cancer, ER+ breast, gastric, ovarian, pancreatic, colorectal, liver or anaplastic thyroid cancer who have exhausted all licenced therapeutic options will die due to their disease. Based on the investigator's existing data CLEVER-1 is expressed in these tumour types. Inhibition of CLEVER-1 with FP-1305 may have an anti-tumour effect in these patients.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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