CancerPhase 1/2NCT03733990
A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients (MATINS)
A Phase 1/2 study testing FP-1305 (bexmarilimab) in people with Cancer, run by Faron Pharmaceuticals Ltd at 11 sites in 6 countries.
Trial summary
This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1. CLEVER-1 has been shown to support tumour growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- FP-1305 (bexmarilimab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 3 Dec 2018to 31 Oct 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Less than 21 days since the last dose of intravenous anticancer chemotherapy or less than five half-lives from a small molecule targeted therapy or oral anticancer chemotherapy before the first IMP administration
- Any immunotherapy within preceding 6 weeks from the first IMP administration
- Investigational therapy or major surgery within 4 weeks from the date of consent
- Active clinically serious infection > Grade 2 NCI-CTCAE version 5.0 (Appendix 5 - Common Toxicity Criteria Gradings) within preceding 2 weeks from the date of consent
- Brain metastases
- Subject has not recovered from the previous therapies to Grade ≤ 1 severity as classified by the NCI-CTCAE version 5.0 (except Grade ≤ 2 alopecia, neuropathy or thyroid disorders)
Show all 24Show fewer
- Pregnant or lactating women
- History of second malignancy except for non-melanotic skin cancer, cervical carcinoma in situ or superficial bladder cancer, or any other malignancy treated previously with curative intent and more than three years without relapse
- Evidence of severe or uncontrolled systemic diseases, congestive cardiac failure New York Heart Association (NYHA) class 2 (Appendix 7 - NYHA classification), Myocardial Infarction (MI) within 6 months or laboratory finding that in the view of the investigator makes it undesirable for the subject to participate in the trial
- Any medical condition that the Investigator considers significant to compromise the safety of the subject or that impairs the interpretation of IMP toxicity assessment
- Confirmed human immunodeficiency virus infection
- Symptomatic cytomegalovirus infection
- Subjects with active auto-immune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia)
- The subject requires systemic corticosteroid or other immunosuppressive treatment
- Subjects with organ transplants
- Subjects in dialysis
- Use of Live (attenuated) vaccines for 30 days prior to the start of study treatment, during treatment, and until last visit
- Subject is unwilling or unable to comply with treatment and trial instructions
- Subjects with known hypersensitivity to the IMP or any of the pharmaceutical ingredients
- Specific Additional Exclusion Criteria for Hepatobiliary Cancers
- Any ablative therapy (Radio Frequency Ablation or Percutaneous Ethanol Injection) for HCC (this should not exclude subjects if target lesion(s) have not been treated and occurred > 6 weeks prior trial entry)
- Hepatic encephalopathy
- Ascites refractory to diuretic therapy
- Child-Pugh score ≥ 7
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
Finland4 sites
Clinical Research Institute HUCH Ltd
Helsinki, 00290
Oulu University Hospital
Oulu, 90220
Tampere University Hospital
Tampere, 33520
Turku University Hospital
Turku, 20520
United Kingdom3 sites
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW
The Christie NHS Foundation Trust
Manchester, M20 4BX
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3901
Netherlands1 site
Erasmus University Medical Center Rotterdam
Rotterdam, 3015 GD
About this study
Official title: A Phase I/II Open-Label, Three-Part, Dose-Finding and Separate Cohort Expansion Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Repeated Doses of CLEVER-1 Antibody FP-1305, in Subjects With Advanced Solid Tumours
This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1. CLEVER-1 has been shown to support tumour growth. No significant adverse events were witnessed in primates and the dose used will be 300 fold lower than the dose provided to primates which showed no toxicity.
The patients with advanced melanoma, uveal melanoma, cholangiocarcinoma, gallbladder cancer, ER+ breast, gastric, ovarian, pancreatic, colorectal, liver or anaplastic thyroid cancer who have exhausted all licenced therapeutic options will die due to their disease. Based on the investigator's existing data CLEVER-1 is expressed in these tumour types. Inhibition of CLEVER-1 with FP-1305 may have an anti-tumour effect in these patients.
- Conditions
- Cancer
- Being tested
- FP-1305 (bexmarilimab)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FP-1305 (bexmarilimab)Biological
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| FP-1305 (bexmarilimab) 0.3 mg/kg | Experimental | Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals Receives: Biological: FP-1305 (bexmarilimab) |
| FP-1305 (bexmarilimab) 1 mg/kg | Experimental | Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals Receives: Biological: FP-1305 (bexmarilimab) |
| FP-1305 (bexmarilimab) 3 mg/kg | Experimental | Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals Receives: Biological: FP-1305 (bexmarilimab) |
| FP-1305 (bexmarilimab) 10 mg/kg | Experimental | Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals Receives: Biological: FP-1305 (bexmarilimab) |
| FP-1305 (bexmarilimab) 0.1 mg/kg | Experimental | Part I Dose-escalation FP-1305 0.1 mg/kg is administered in three-week intervals Receives: Biological: FP-1305 (bexmarilimab) |
| FP-1305 (bexmarilimab) 30 mg/kg | Experimental | Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals Receives: Biological: FP-1305 (bexmarilimab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT) in the Trial Subjects.
Tolerable dose(s) will be determined by the TITE-CRM based on the occurrence/non-occurrence of dose limiting toxicities in the trial subjects.
Measured: Up to one year
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
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.
Measured: approximately 4 years and 9 months
The Response Objective Response Rate (ORR) to the Treatment Was Planned to be Determined by Tumor Imaging According to RECIST 1.1.
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.
Measured: approximately 4 years and 9 months
The Disease Control Rate (DCR) Response to the Treatment Was Planned to be Determined by Tumor Imaging According to RECIST 1.1.
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)
Measured: approximately 4 years and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start3 Dec 2018
- Primary completion6 Sep 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose-escalation, six dose levels
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faron Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petri Bono, MD, PhD, Principal investigator, Terveystalo Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733990
- Sponsor's protocol ID
- FP2CLI001
- Other IDs
- 2018-002732-24, 2018
- Status last verified
- Mar 2025
- First submitted
- 23 Oct 2018
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rannikko JH, Verlingue L, de Miguel M, Pasanen A, Robbrecht D, Skytta T, Iivanainen S, Shetty S, Ma YT, Graham DM, Arora SP, Jaakkola P, Yap C, Xiang Y, Mandelin J, Karvonen MK, Jalkanen J, Karaman S, Koivunen JP, Minchom A, Hollmen M, Bono P. Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors: The phase I/II first-in-human MATINS trial. Cell Rep Med. 2023 Dec 19;4(12):101307. doi: 10.1016/j.xcrm.2023.101307. Epub 2023 Dec 5.
PubMed 38056464Hollmen M, Maksimow M, Rannikko JH, Karvonen MK, Vainio M, Jalkanen S, Jalkanen M, Mandelin J. Nonclinical Characterization of Bexmarilimab, a Clever-1-Targeting Antibody for Supporting Immune Defense Against Cancers. Mol Cancer Ther. 2022 Jul 5;21(7):1207-1218. doi: 10.1158/1535-7163.MCT-21-0840.
PubMed 35500016Virtakoivu R, Rannikko JH, Viitala M, Vaura F, Takeda A, Lonnberg T, Koivunen J, Jaakkola P, Pasanen A, Shetty S, de Jonge MJA, Robbrecht D, Ma YT, Skytta T, Minchom A, Jalkanen S, Karvonen MK, Mandelin J, Bono P, Hollmen M. Systemic Blockade of Clever-1 Elicits Lymphocyte Activation Alongside Checkpoint Molecule Downregulation in Patients with Solid Tumors: Results from a Phase I/II Clinical Trial. Clin Cancer Res. 2021 Aug 1;27(15):4205-4220. doi: 10.1158/1078-0432.CCR-20-4862. Epub 2021 Jun 2.
PubMed 34078651
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-Label, Three-Part, Dose-Finding and Separate Cohort Expansion Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Repeated Doses of CLEVER-1 Antibody FP-1305, in Subjects With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT03733990
- Acronym / sponsor ID
- FP2CLI001
- Conditions
- Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Faron Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1. CLEVER-1 has been shown to support tumour growth. No significant adverse events were witnessed in primates and the dose used will be 300 fold lower than the dose provided to primates which showed no toxicity.
The patients with advanced melanoma, uveal melanoma, cholangiocarcinoma, gallbladder cancer, ER+ breast, gastric, ovarian, pancreatic, colorectal, liver or anaplastic thyroid cancer who have exhausted all licenced therapeutic options will die due to their disease. Based on the investigator's existing data CLEVER-1 is expressed in these tumour types. Inhibition of CLEVER-1 with FP-1305 may have an anti-tumour effect in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Dose-escalation, six dose levels
| Arm | Type | Receives |
|---|---|---|
| FP-1305 (bexmarilimab) 0.3 mg/kg | Experimental | Biological: FP-1305 (bexmarilimab)Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals |
| FP-1305 (bexmarilimab) 1 mg/kg | Experimental | Biological: FP-1305 (bexmarilimab)Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals |
| FP-1305 (bexmarilimab) 3 mg/kg | Experimental | Biological: FP-1305 (bexmarilimab)Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals |
| FP-1305 (bexmarilimab) 10 mg/kg | Experimental | Biological: FP-1305 (bexmarilimab)Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals |
| FP-1305 (bexmarilimab) 0.1 mg/kg | Experimental | Biological: FP-1305 (bexmarilimab)Part I Dose-escalation FP-1305 0.1 mg/kg is administered in three-week intervals |
| FP-1305 (bexmarilimab) 30 mg/kg | Experimental | Biological: FP-1305 (bexmarilimab)Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (24 listed)
- Less than 21 days since the last dose of intravenous anticancer chemotherapy or less than five half-lives from a small molecule targeted therapy or oral anticancer chemotherapy before the first IMP administration
- Any immunotherapy within preceding 6 weeks from the first IMP administration
- Investigational therapy or major surgery within 4 weeks from the date of consent
- Active clinically serious infection > Grade 2 NCI-CTCAE version 5.0 (Appendix 5 - Common Toxicity Criteria Gradings) within preceding 2 weeks from the date of consent
- Brain metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FP-1305 (bexmarilimab)Also: bexmarilimabThe 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. | Biological | FP-1305 (bexmarilimab) 0.1 mg/kg, FP-1305 (bexmarilimab) 0.3 mg/kg, FP-1305 (bexmarilimab) 1 mg/kg, FP-1305 (bexmarilimab) 10 mg/kg, FP-1305 (bexmarilimab) 3 mg/kg, FP-1305 (bexmarilimab) 30 mg/kg |
Primary outcome
Dose Limiting Toxicities (DLT) in the Trial Subjects.
Time frame: Up to one year
Tolerable dose(s) will be determined by the TITE-CRM based on the occurrence/non-occurrence of dose limiting toxicities in the trial subjects.
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
Time frame: approximately 4 years and 9 months
Number of adverse events and serious adverse events. Adverse events are collected, graded and reported according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
The Response Objective Response Rate (ORR) to the Treatment Was Planned to be Determined by Tumor Imaging According to RECIST 1.1.
Time frame: approximately 4 years and 9 months
The objective response rate (ORR) to the treatment will be determined by tumour imaging (tumor size) according to RECIST v.1.1. Results from each tumour type, dose level and dosing frequency are reported separately.
The Disease Control Rate (DCR) Response to the Treatment Was Planned to be Determined by Tumor Imaging According to RECIST 1.1.
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38056464Rannikko JH, Verlingue L, de Miguel M, Pasanen A, Robbrecht D, Skytta T, Iivanainen S, Shetty S, Ma YT, Graham DM, Arora SP, Jaakkola P, Yap C, Xiang Y, Mandelin J, Karvonen MK, Jalkanen J, Karaman S, Koivunen JP, Minchom A, Hollmen M, Bono P. Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors: The phase I/II first-in-human MATINS trial. Cell Rep Med. 2023 Dec 19;4(12):101307. doi: 10.1016/j.xcrm.2023.101307. Epub 2023 Dec 5.
- Derived from this study: PubMed 35500016Hollmen M, Maksimow M, Rannikko JH, Karvonen MK, Vainio M, Jalkanen S, Jalkanen M, Mandelin J. Nonclinical Characterization of Bexmarilimab, a Clever-1-Targeting Antibody for Supporting Immune Defense Against Cancers. Mol Cancer Ther. 2022 Jul 5;21(7):1207-1218. doi: 10.1158/1535-7163.MCT-21-0840.
- Derived from this study: PubMed 34078651Virtakoivu R, Rannikko JH, Viitala M, Vaura F, Takeda A, Lonnberg T, Koivunen J, Jaakkola P, Pasanen A, Shetty S, de Jonge MJA, Robbrecht D, Ma YT, Skytta T, Minchom A, Jalkanen S, Karvonen MK, Mandelin J, Bono P, Hollmen M. Systemic Blockade of Clever-1 Elicits Lymphocyte Activation Alongside Checkpoint Molecule Downregulation in Patients with Solid Tumors: Results from a Phase I/II Clinical Trial. Clin Cancer Res. 2021 Aug 1;27(15):4205-4220. doi: 10.1158/1078-0432.CCR-20-4862. Epub 2021 Jun 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petri Bono, MD, PhD principal investigator
Terveystalo Ltd
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FP-1305 (bexmarilimab) in people with Cancer, run by Faron Pharmaceuticals Ltd at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Finland, United Kingdom, United States, France, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLT) in the Trial Subjects. (time frame: Up to one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03733990, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.