Ovarian Cancer Clinical Trial

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

Summary

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

The patients with advanced melanoma, uveal melanoma, cholangiocarcinoma, gallbladder cancer, ER+ breast, gastric, ovarian, pancreatic, colorectal, liver or anaplastic thyroid cancer who have exhausted all licenced therapeutic options will die due to their disease. Based on the investigator's existing data CLEVER-1 is expressed in these tumour types. Inhibition of CLEVER-1 with FP-1305 may have an anti-tumour effect in these patients.

View Eligibility Criteria

Eligibility Criteria

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

Written Informed Consent
Aged ≥ 18 years male or female
Tumour sample should be collected during screening period. If a recent tumour biopsy obtained within six months before the date of consent is available (or older, as agreed on a case by case basis with the sponsor), that may be used. At the discretion of the sponsor, the tumour sample may be optional for certain subjects in Part III
Life expectancy > 12 weeks

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
Anaplastic thyroid cancer in Parts II and III
ECOG performance status 0 or 1
Measurable disease in Parts II and III
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.
Women of child-bearing potential must have a negative pregnancy test in serum prior to trial entry
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;

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)
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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

700

Study ID:

NCT03733990

Recruitment Status:

Recruiting

Sponsor:

Faron Pharmaceuticals Ltd

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There are 11 Locations for this study

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The University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States More Info
Sukeshi Patel Arora, MD, PhD
Contact
Clinical Research Institute HUCH Ltd
Helsinki , 00290, Finland More Info
Kristiina Karihtala, MD
Contact
Oulu University Hospital
Oulu , 90220, Finland More Info
Sanna Iivanainen, MD, PhD
Contact
Tampere University Hospital
Tampere , 33520, Finland More Info
Tanja Skyttä, MD, PhD
Contact
Turku University Hospital
Turku , 20520, Finland More Info
Panu Jaakkola, MD, PhD
Contact
The Institut Gustave Roussy
Villejuif , 94805, France More Info
Rastislav Bahleda, MD
Contact
Erasmus University Medical Center Rotterdam
Rotterdam , 3015 , Netherlands More Info
Maja deJonge, MD, PhD
Contact
START Madrid - CIOCC Hospital HM Sanchinarro
Madrid , 28050, Spain More Info
María José de Miguel, MD, PhD
Contact
The Royal Marsden NHS Foundation Trust
Sutton Surrey, SM2 5, United Kingdom More Info
Anna Minchom, MD, PhD
Contact
Queen Elizabeth Hospital Birmingham
Birmingham , B15 2, United Kingdom More Info
Yuk Ting Ma, MD, PhD
Contact
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom More Info
Donna Graham, MD, PhD
Contact

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

700

Study ID:

NCT03733990

Recruitment Status:

Recruiting

Sponsor:


Faron Pharmaceuticals Ltd

How clear is this clinincal trial information?

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