A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients (MATINS)

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
FP-1305 (bexmarilimab) 0.1 mg/kg	FP-1305 (bexmarilimab)	Part I Dose-escalation FP-1305 0.1 mg/kg is administered in three-week intervals
FP-1305 (bexmarilimab) 3 mg/kg	FP-1305 (bexmarilimab)	Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals
FP-1305 (bexmarilimab) 0.3 mg/kg	FP-1305 (bexmarilimab)	Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals
FP-1305 (bexmarilimab) 10 mg/kg	FP-1305 (bexmarilimab)	Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals
FP-1305 (bexmarilimab) 1 mg/kg	FP-1305 (bexmarilimab)	Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals
FP-1305 (bexmarilimab) 30 mg/kg	FP-1305 (bexmarilimab)	Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities (DLT) in the Trial Subjects.	Up to one year	Tolerable dose(s) will be determined by the TITE-CRM based on the occurrence/non-occurrence of dose limiting toxicities in the trial subjects.
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)	approximately 4 years and 9 months	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.
The Response Objective Response Rate (ORR) to the Treatment Was Planned to be Determined by Tumor Imaging According to RECIST 1.1.	approximately 4 years and 9 months	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.
The Disease Control Rate (DCR) Response to the Treatment Was Planned to be Determined by Tumor Imaging According to RECIST 1.1.	approximately 4 years and 9 months	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)

Secondary Outcome Measures

Name	Time	Method

Locations (11): Oulu University Hospital
🇫🇮
Oulu, Finland
Tampere University Hospital
🇫🇮
Tampere, Finland
Clinical Research Institute HUCH Ltd
🇫🇮
Helsinki, Finland
Turku University Hospital
🇫🇮
Turku, Finland
The Royal Marsden NHS Foundation Trust
🇬🇧
Sutton, Surrey, United Kingdom
The Christie NHS Foundation Trust
🇬🇧
Manchester, United Kingdom
The Institut Gustave Roussy
🇫🇷
Villejuif, France
The University of Texas Health Science Center at San Antonio
🇺🇸
San Antonio, Texas, United States
START Madrid - CIOCC Hospital HM Sanchinarro
🇪🇸
Madrid, Spain
Queen Elizabeth Hospital Birmingham
🇬🇧
Birmingham, United Kingdom
Erasmus University Medical Center Rotterdam
🇳🇱
Rotterdam, Netherlands