Trial Outcomes & Findings for A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients (MATINS) (NCT NCT03733990)

NCT ID: NCT03733990

Last Updated: 2025-04-02

Results Overview

Tolerable dose(s) will be determined by the TITE-CRM based on the occurrence/non-occurrence of dose limiting toxicities in the trial subjects.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 216 participants
• Primary outcome timeframe: Up to one year
• Results posted on: 2025-04-02

Participant Flow

Participant milestones

Measure	FP-1305 (Bexmarilimab) 0.3 mg/kg Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 1 mg/kg Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 3 mg/kg Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 10 mg/kg Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 0.1 mg/kg Part I Dose-escalation FP-1305 0.1 mg/kg is administered in three-week intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 30 mg/kg Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.
Overall Study STARTED	13	130	41	18	5	9
Overall Study COMPLETED	13	130	41	18	5	9
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	FP-1305 (Bexmarilimab) 0.3 mg/kg n=13 Participants Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 1 mg/kg n=130 Participants Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 3 mg/kg n=41 Participants Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 10 mg/kg n=18 Participants Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 0.1 mg/kg n=5 Participants Part I Dose-escalation FP-1305 0.1 mg/kg is administered in three-week intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 30 mg/kg n=9 Participants Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	Total n=216 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	91 Participants n=7 Participants	25 Participants n=5 Participants	9 Participants n=4 Participants	3 Participants n=21 Participants	8 Participants n=8 Participants	139 Participants n=8 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	39 Participants n=7 Participants	16 Participants n=5 Participants	9 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	77 Participants n=8 Participants
Age, Continuous	67.15 years STANDARD_DEVIATION 5.444 • n=5 Participants	59.67 years STANDARD_DEVIATION 10.563 • n=7 Participants	61.80 years STANDARD_DEVIATION 11.023 • n=5 Participants	61.44 years STANDARD_DEVIATION 13.321 • n=4 Participants	57.60 years STANDARD_DEVIATION 16.950 • n=21 Participants	57.33 years STANDARD_DEVIATION 6.690 • n=8 Participants	60.53 years STANDARD_DEVIATION 10.787 • n=8 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	60 Participants n=7 Participants	19 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=8 Participants	104 Participants n=8 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	70 Participants n=7 Participants	22 Participants n=5 Participants	12 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	112 Participants n=8 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized White	10 Participants n=5 Participants	106 Participants n=7 Participants	33 Participants n=5 Participants	12 Participants n=4 Participants	5 Participants n=21 Participants	8 Participants n=8 Participants	174 Participants n=8 Participants
Race/Ethnicity, Customized Not reported	0 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	18 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	33 Participants n=8 Participants
Region of Enrollment Netherlands	2 participants n=5 Participants	16 participants n=7 Participants	8 participants n=5 Participants	4 participants n=4 Participants	0 participants n=21 Participants	1 participants n=8 Participants	31 participants n=8 Participants
Region of Enrollment United States	0 participants n=5 Participants	4 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	5 participants n=8 Participants
Region of Enrollment Finland	6 participants n=5 Participants	43 participants n=7 Participants	12 participants n=5 Participants	3 participants n=4 Participants	5 participants n=21 Participants	3 participants n=8 Participants	72 participants n=8 Participants
Region of Enrollment United Kingdom	5 participants n=5 Participants	21 participants n=7 Participants	8 participants n=5 Participants	3 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	37 participants n=8 Participants
Region of Enrollment France	0 participants n=5 Participants	26 participants n=7 Participants	5 participants n=5 Participants	4 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	35 participants n=8 Participants
Region of Enrollment Spain	0 participants n=5 Participants	20 participants n=7 Participants	8 participants n=5 Participants	3 participants n=4 Participants	0 participants n=21 Participants	5 participants n=8 Participants	36 participants n=8 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	FP-1305 (Bexmarilimab) 0.3 mg/kg n=13 Participants Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 1 mg/kg n=130 Participants Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 3 mg/kg n=41 Participants Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 10 mg/kg n=18 Participants Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 0.1 mg/kg n=5 Participants Part I Dose-escalation FP-1305 0.1 mg/kg is administered in three-week intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 30 mg/kg n=9 Participants Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.
Dose Limiting Toxicities (DLT) in the Trial Subjects.	0 DLT	0 DLT	0 DLT	0 DLT	0 DLT	0 DLT

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	FP-1305 (Bexmarilimab) 0.3 mg/kg n=13 Participants Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 1 mg/kg n=130 Participants Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 3 mg/kg n=41 Participants Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 10 mg/kg n=18 Participants Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 0.1 mg/kg n=5 Participants Part I Dose-escalation FP-1305 0.1 mg/kg is administered in three-week intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 30 mg/kg n=9 Participants Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)	13 Participants	122 Participants	38 Participants	17 Participants	5 Participants	9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	FP-1305 (Bexmarilimab) 0.3 mg/kg n=13 Participants Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 1 mg/kg n=130 Participants Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 3 mg/kg n=41 Participants Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 10 mg/kg n=18 Participants Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 0.1 mg/kg n=5 Participants Part I Dose-escalation FP-1305 0.1 mg/kg is administered in three-week intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 30 mg/kg n=9 Participants Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.
The Response Objective Response Rate (ORR) to the Treatment Was Planned to be Determined by Tumor Imaging According to RECIST 1.1.	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	FP-1305 (Bexmarilimab) 0.3 mg/kg n=13 Participants Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 1 mg/kg n=130 Participants Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 3 mg/kg n=41 Participants Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 10 mg/kg n=18 Participants Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 0.1 mg/kg n=5 Participants Part I Dose-escalation FP-1305 0.1 mg/kg is administered in three-week intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 30 mg/kg n=9 Participants Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.
The Disease Control Rate (DCR) Response to the Treatment Was Planned to be Determined by Tumor Imaging According to RECIST 1.1.	1 Participants	20 Participants	4 Participants	2 Participants	0 Participants	1 Participants

Adverse Events

FP-1305 (Bexmarilimab) 0.3 mg/kg

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

FP-1305 (Bexmarilimab) 1 mg/kg

Serious events: 57 serious events

Other events: 122 other events

Deaths: 12 deaths

FP-1305 (Bexmarilimab) 3 mg/kg

Serious events: 13 serious events

Other events: 38 other events

Deaths: 3 deaths

FP-1305 (Bexmarilimab) 10 mg/kg

Serious events: 10 serious events

Other events: 17 other events

Deaths: 3 deaths

FP-1305 (Bexmarilimab) 0.1 mg/kg

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

FP-1305 (Bexmarilimab) 30 mg/kg

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	FP-1305 (Bexmarilimab) 0.3 mg/kg n=13 participants at risk Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 1 mg/kg n=130 participants at risk Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 3 mg/kg n=41 participants at risk Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 10 mg/kg n=18 participants at risk Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 0.1 mg/kg n=5 participants at risk Part I Dose-escalation FP-1305 0.1 mg/kg is administered in three-week intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 30 mg/kg n=9 participants at risk Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	1.5% 2/130 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Blood and lymphatic system disorders Anaemia	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Blood and lymphatic system disorders Pancytopenia	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Cardiac disorders Atrial fibrillation	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Cardiac disorders Cardiac tamponade	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Cardiac disorders Myocardial infarction	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Endocrine disorders Adrenocortical insufficiency acute	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	11.1% 1/9 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Ascites	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	3.8% 5/130 • Number of events 7 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	4.9% 2/41 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	40.0% 2/5 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Abdominal pain	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	3.8% 5/130 • Number of events 5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Vomiting	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.3% 3/130 • Number of events 3 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	4.9% 2/41 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Intestinal obstruction	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	1.5% 2/130 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	11.1% 1/9 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Diarrhoea	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.4% 1/41 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Constipation	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	1.5% 2/130 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Dysphagia	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.4% 1/41 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Ileus	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	1.5% 2/130 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Nausea	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.4% 1/41 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	1.5% 2/130 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Duodenal obstruction	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Gastric ulcer	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
General disorders Death	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.3% 3/130 • Number of events 3 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	7.3% 3/41 • Number of events 3 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
General disorders Pyrexia	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	1.5% 2/130 • Number of events 3 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.4% 1/41 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	20.0% 1/5 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
General disorders General physical health deterioration	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	1.5% 2/130 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	20.0% 1/5 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
General disorders Fatigue	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Hepatobiliary disorders Cholestasis	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	11.1% 2/18 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Hepatobiliary disorders Hepatic pain	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Hepatobiliary disorders Cholangitis	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.4% 1/41 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Hepatobiliary disorders Hepatic failure	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Hepatobiliary disorders Hepatitis	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.4% 1/41 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Hepatobiliary disorders Jaundice	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.4% 1/41 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Infections and infestations Pneumonia	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	1.5% 2/130 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.4% 1/41 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Infections and infestations Biliary sepsis	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.4% 1/41 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Infections and infestations Bacteraemia	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	11.1% 1/9 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Infections and infestations Infected seroma	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	20.0% 1/5 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Infections and infestations Infection	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Infections and infestations Pneumonia viral	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Infections and infestations Pyelonephritis	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Infections and infestations Respiratory syncytial virus infection	7.7% 1/13 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Infections and infestations Respiratory tract infection	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Infections and infestations Sepsis	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Investigations Transaminases increased	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.3% 3/130 • Number of events 3 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Investigations Blood bilirubin increased	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Investigations Liver function test abnormal	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	4.9% 2/41 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	1.5% 2/130 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal pain	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to oesophagus	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Nervous system disorders Spinal cord compression	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.4% 1/41 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Nervous system disorders Cerebellar infarction	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Nervous system disorders Hepatic encephalopathy	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Nervous system disorders Hydrocephalus	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.4% 1/41 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Nervous system disorders Motor dysfunction	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Nervous system disorders Somnolence	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Product Issues Device occlusion	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Renal and urinary disorders Renal disorder	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	3.1% 4/130 • Number of events 4 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	11.1% 1/9 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Respiratory, thoracic and mediastinal disorders Immune-mediated pneumonitis	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.77% 1/130 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Vascular disorders Haematoma	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/130 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition

Other adverse events

Measure	FP-1305 (Bexmarilimab) 0.3 mg/kg n=13 participants at risk Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 1 mg/kg n=130 participants at risk Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 3 mg/kg n=41 participants at risk Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 10 mg/kg n=18 participants at risk Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 0.1 mg/kg n=5 participants at risk Part I Dose-escalation FP-1305 0.1 mg/kg is administered in three-week intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.	FP-1305 (Bexmarilimab) 30 mg/kg n=9 participants at risk Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab): The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.
Blood and lymphatic system disorders Blood and lymphatic system disorders	15.4% 2/13 • Number of events 3 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	24.6% 32/130 • Number of events 52 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	26.8% 11/41 • Number of events 15 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	33.3% 6/18 • Number of events 11 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	20.0% 1/5 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	22.2% 2/9 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Cardiac disorders Cardiac disorders	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.3% 3/130 • Number of events 7 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	2.4% 1/41 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Endocrine disorders Endocrine disorders	7.7% 1/13 • Number of events 3 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	3.1% 4/130 • Number of events 4 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Gastrointestinal disorders Gastrointestinal disorders	53.8% 7/13 • Number of events 13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	37.7% 49/130 • Number of events 145 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	48.8% 20/41 • Number of events 44 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	27.8% 5/18 • Number of events 22 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	40.0% 2/5 • Number of events 11 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	55.6% 5/9 • Number of events 8 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
General disorders General disorders and administration site conditions	61.5% 8/13 • Number of events 15 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	43.8% 57/130 • Number of events 99 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	39.0% 16/41 • Number of events 24 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	61.1% 11/18 • Number of events 16 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	60.0% 3/5 • Number of events 6 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	66.7% 6/9 • Number of events 8 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Hepatobiliary disorders Hepatobiliary disorders	15.4% 2/13 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.4% 7/130 • Number of events 16 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	7.3% 3/41 • Number of events 4 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Infections and infestations Infections and infestations	15.4% 2/13 • Number of events 3 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	12.3% 16/130 • Number of events 22 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	17.1% 7/41 • Number of events 11 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	40.0% 2/5 • Number of events 3 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	22.2% 2/9 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	15.4% 2/13 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	3.8% 5/130 • Number of events 8 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	7.3% 3/41 • Number of events 4 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	11.1% 1/9 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Investigations Investigations	30.8% 4/13 • Number of events 10 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	30.8% 40/130 • Number of events 104 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	24.4% 10/41 • Number of events 22 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	33.3% 6/18 • Number of events 18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	40.0% 2/5 • Number of events 7 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	33.3% 3/9 • Number of events 7 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Metabolism and nutrition disorders Metabolism and nutrition disorders	23.1% 3/13 • Number of events 5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	27.7% 36/130 • Number of events 55 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	24.4% 10/41 • Number of events 26 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	44.4% 8/18 • Number of events 12 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	20.0% 1/5 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	38.5% 5/13 • Number of events 10 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	19.2% 25/130 • Number of events 47 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	29.3% 12/41 • Number of events 18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	27.8% 5/18 • Number of events 8 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	20.0% 1/5 • Number of events 2 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	6.9% 9/130 • Number of events 11 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	9.8% 4/41 • Number of events 5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	11.1% 2/18 • Number of events 3 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	20.0% 1/5 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Nervous system disorders Nervous system disorders	23.1% 3/13 • Number of events 5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	10.8% 14/130 • Number of events 25 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	14.6% 6/41 • Number of events 14 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.6% 1/18 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	66.7% 6/9 • Number of events 6 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Renal and urinary disorders Renal and urinary disorders	7.7% 1/13 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	5.4% 7/130 • Number of events 8 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/41 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/18 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	30.8% 4/13 • Number of events 5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	16.2% 21/130 • Number of events 30 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	9.8% 4/41 • Number of events 5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	16.7% 3/18 • Number of events 3 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	20.0% 1/5 • Number of events 1 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	11.1% 1/9 • Number of events 3 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition
Vascular disorders Vascular disorders	0.00% 0/13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	10.0% 13/130 • Number of events 13 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	12.2% 5/41 • Number of events 5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	11.1% 2/18 • Number of events 5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/5 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition	0.00% 0/9 • Approximately 4 years and 11 months As per clinicaltrials.gov's adverse event definition

Additional Information

Chief Medical Officer

Faron Pharmaceuticals Ltd

Phone: +35824695151

Email: info@faron.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place