A Study to evaluate safety, tolerability and preliminary efficacy of FP-1305 in cancer patients

Phase 1

Conditions: Selected solid tumours
- cutaneous melanoma - pancreatic ductal adenocarcinoma- ovarian cancer- colorectal adenocarcinoma- hepatocellular carcinoma- gallbladder cancer and cholangiocarcinoma- uveal melanoma- gastric adenocarcinoma (including GE junction)- estrogen receptor positive breast cancer- anaplastic thyroid cancer
MedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2018-002732-24-FI

Lead Sponsor: Faron Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 700

Inclusion Criteria

1)Written Informed Consent
2)Aged = 18 years male or female
3)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
4)Life expectancy > 12 weeks
5)Histologically confirmed advanced (inoperable or metastatic) malignancies in which (according to the view of the investigator) no curative, effective or suitable treatment options exist:
oHepatocellular carcinoma
oGallbladder cancer or intra- or extrahepatic cholangiocarcinoma
oColorectal adenocarcinoma
oSerous poorly differentiated (Grade 3) ovarian adenocarcinoma or undifferentiated ovarian cancer
oPancreatic ductal adenocarcinoma
oImmunotherapy (IO) resistant cutaneous melanoma (progression during programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) or cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody therapy)
oUveal melanoma in Parts II and III
oGastric adenocarcinoma (including adenocarcinoma of the distal esophagus / GE junction) in Parts II and III
oER+ breast cancer in Parts II and III
oAnaplastic thyroid 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 = 1x109/L
Blood platelet count = 100x109/L, for HCC = 50x109/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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280

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 before the first IMP administration
4)Active clinically serious infection > Grade 2 NCI-CTCAE version 5.0 within preceding 2 weeks before the first IMP administration
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 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
9)Evidence of severe or uncontrolled systemic diseases, congestive cardiac failure New York Heart Association class = 2, Myocardial Infarction 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
19)Subjects with known hypersensitivity to the IMP or any of the pharmaceutical ingredients

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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