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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03733990
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Faron Pharmaceuticals Ltd

Brief Summary:

This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1. CLEVER-1 has been shown to support tumour growth. No significant adverse events were witnessed in primates and the dose used will be 300 fold lower than the dose provided to primates which showed no toxicity.

The patients with advanced melanoma, uveal melanoma, cholangiocarcinoma, gallbladder cancer, ER+ breast, gastric, ovarian, pancreatic, colorectal or liver 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.


Condition or disease Intervention/treatment Phase
Cancer Biological: FP-1305 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose-escalation, five dose levels
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2024

Arm Intervention/treatment
Experimental: FP-1305 0.3 mg/kg
Part I/ Dose-escalation FP-1305 0.3 mg/kg is administered in three-week intervals
Biological: FP-1305
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.

Experimental: FP-1305 1 mg/kg
Part I, Dose-escalation FP-1305 1 mg/kg is administered in three-week intervals
Biological: FP-1305
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.

Experimental: FP-1305 3 mg/kg
Part I, Dose-escalation FP-1305 3 mg/kg is administered in three-week intervals
Biological: FP-1305
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.

Experimental: FP-1305 10 mg/kg
Part I, Dose-escalation FP-1305 10 mg/kg is administered in three-week intervals
Biological: FP-1305
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.

Experimental: FP-1305 0.1 mg/kg
Part I/ Dose-escalation FP-1305 0.1 mg/kg is administered in three-week intervals
Biological: FP-1305
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.




Primary Outcome Measures :
  1. 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.

  2. Incidence of Treatment - Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Up to six years ]
    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.

  3. CLEVER-1 positivity in the tumour. [ Time Frame: Up to six years ]
    CLEVER-1 in tumour sample prior to treatment will be identified with immunohistochemistry and reported as positive cells / mm2 of sample.

  4. The objective response rate (ORR) of the treatment. [ Time Frame: Up to six years ]
    The objective response rate (ORR) to the treatment will be determined by tumour imaging (tumor size) according to RECIST v.1.1. ORR will be reported as the proportion of subjects of all evaluable subjects.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in the clinical trial:

  1. Written Informed Consent
  2. Aged ≥ 18 years male or female
  3. Recent (less than six months old from the date of consent) tumour sample obtained for biomarker analysis in Parts I and II (optional in Part III)
  4. Life expectancy > 12 weeks
  5. Histologically confirmed advanced (inoperable or metastatic) malignancies without standard therapeutic options available:

    • Hepatocellular carcinoma
    • Gallbladder cancer or intra- or extrahepatic cholangiocarcinoma
    • Colorectal adenocarcinoma
    • Serous poorly differentiated (Grade 3) ovarian adenocarcinoma or undifferentiated ovarian cancer
    • Pancreatic ductal adenocarcinoma
    • Immunotherapy (IO) refractory cutaneous melanoma (progression either on or after programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) or cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody therapy)
    • Uveal melanoma in Parts II and III
    • Gastric adenocarcinoma (including adenocarcinoma of the distal esophagus / GE junction) in Parts II and III
    • ER+ breast cancer in Parts II and III
  6. ECOG performance status 0 or 1
  7. Measurable disease in Parts II and III
  8. Adequate bone marrow, liver and kidney function defined as Blood white blood cell ≥ lower limit of normal Blood neutrophil count ≥ 1x10(9)/L Blood platelet count ≥ 100x10(9)/L, for HCC ≥ 50x10(9)/L Blood haemoglobin ≥ 9.0 g/dL Creatinine clearance > 40 mL/min calculated by Cockcroft-Gault formula AST ≤ 3 X ULN (≤ 5 x ULN when HCC or hepatic metastases are present) ALT ≤ 3 X ULN (≤ 5 x ULN when HCC or hepatic metastases present) Bilirubin ≤ 1.5 X ULN Albumin ≥ 3.0 g/dL The most recent measurements taken during the screening period must be within the required limits for the patient to be considered eligible (i.e. criteria met once during the screening period are not sufficient if there are more recent measurements available that are not within the required limits. It is however acceptable to repeat measurements if the initial measurements or subsequent measurements taken during the screening period are not within the required limits; the patient is eligible providing that the newest measurements are within the required limits). However, once a subject is out of the screening period, and has had eligibility confirmed and been enrolled, the pre-dose laboratory assessments are not subjected to inclusion criteria limits, but only for investigators assessment of subject safety.
  9. Women of child-bearing potential must have a negative pregnancy test in serum prior to trial entry
  10. Women of child-bearing potential and men who have partners of child-bearing potential must be willing to practise highly effective contraception for the duration of the trial and for three months after the completion of treatment

Exclusion Criteria;

  1. 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
  2. Any immunotherapy within preceding 6 weeks from the first IMP administration
  3. Investigational therapy or major surgery within 4 weeks from the date of consent
  4. 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
  5. Brain metastases
  6. 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)
  7. Pregnant or lactating women
  8. History of second malignancy except those treated with curative intent more than three years previously without relapse and non-melanotic skin cancer, cervical carcinoma in situ or superficial bladder cancer
  9. 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
  10. Any medical condition that the Investigator considers significant to compromise the safety of the subject or that impairs the interpretation of IMP toxicity assessment
  11. Confirmed human immunodeficiency virus infection
  12. Symptomatic cytomegalovirus infection
  13. Subjects with active auto-immune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia)
  14. The subject requires systemic corticosteroid or other immunosuppressive treatment
  15. Subjects with organ transplants
  16. Subjects in dialysis
  17. Use of Live (attenuated) vaccines for 30 days prior to the start of study treatment, during treatment, and until last visit
  18. Subject is unwilling or unable to comply with treatment and trial instructions

Specific Additional Exclusion Criteria for Hepatobiliary Cancers

  1. 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)
  2. Hepatic encephalopathy
  3. Ascites refractory to diuretic therapy
  4. Child-Pugh score ≥ 7

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733990


Contacts
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Contact: Matti Karvonen, MD, PhD 02 469 5151 ext 358 matti.karvonen@faron.com
Contact: Jarna Hannukainen, PhD 02 469 5151 ext 358 jarna.hannukainen@faron.com

Locations
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Finland
Clinical Research Institute HUCH Ltd Recruiting
Helsinki, Finland, 00290
Contact: Annika Pasanen, MD, PhD         
Oulu University Hospital Recruiting
Oulu, Finland, 90220
Contact: Jussi Koivunen, MD, PhD         
Tampere University Hospital Recruiting
Tampere, Finland, 33520
Contact: Tanja Skyttä, MD, PhD         
Netherlands
Erasmus University Medical Center Rotterdam Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Maja deJonge, MD, PhD         
United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Anna Minchom, MD, PhD         
Queen Elizabeth Hospital Birmingham Recruiting
Birmingham, United Kingdom, B15 2GW
Contact: Yuk Ting Ma, MD, PhD         
Sponsors and Collaborators
Faron Pharmaceuticals Ltd
Investigators
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Principal Investigator: Petri Bono, MD, PhD Terveystalo Ltd
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Responsible Party: Faron Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT03733990    
Other Study ID Numbers: FP2CLI001
2018-002732-24 ( EudraCT Number )
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No