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

Phase 1

• Conditions: Selected solid tumours (melanoma, pancreatic ductal adenocarcinoma,ovarian cancer, colorectal adenocarcinoma, hepatocellular carcinoma,gallbladder cancer and cholangiocarcinoma, uveal melanoma, gastricadenocarcinoma (including GE junction) and estrogen receptor positivebreast cancer).; MedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002732-24-NL
• Lead Sponsor: Faron Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-21
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

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 Part II and III
6) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
7) Measurable disease for parts II and III
8) Adequate bone marrow, liver and kidney function defined as
Blood WBC = LLN (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 (upper limit of normal; = 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 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 390
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 260

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) 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 for 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), 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 > or = 7

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified