Selected solid tumours
Conditions
Sponsors
Faron Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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: o Hepatocellular carcinoma o Gallbladder cancer or intra- or extrahepatic cholangiocarcinoma o Colorectal adenocarcinoma o Serous poorly differentiated (Grade 3) ovarian adenocarcinoma or undifferentiated ovarian cancer o Pancreatic ductal adenocarcinoma o Immunotherapy (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) o Uveal melanoma in Parts II and III o Gastric adenocarcinoma (including adenocarcinoma of the distal esophagus / GE junction) in Parts II and III o ER+ breast cancer in Parts II and III o Anaplastic 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine the safety, tolerability and recommended dose of FP-1305 in subjects with advanced solid tumours of the selected tumour types without standard treatment options • To determine the safety, tolerability and preliminary efficacy of FP-1305 monotherapy with the objective response rate (ORR), clinical benefit rate (CBR) and immune-related ORR (irORR) in distinct expansion groups of subjects with advanced solid tumours of the selected tumour types • To assess the ORR, CBR and irORR in distinct expansion groups of subjects with advanced solid tumours in CLEVER-1 positive subjects from selected tumour types at a selected dose;Primary end point(s): • Dose limiting toxicities (DLT) in the trial subjects • Adverse Events • The response (clinical benefit rate (CBR), objective response rate (ORR) and immune-related objective response rate (irORR) separately) to the treatment • CLEVER-1 positivity in each tumour type;Secondary Objective: • To study PK after different doses • To assess the host immune response to FP-1305 (immunogenicity) • To assess the preliminary efficacy of FP-1305 monotherapy with the objective response rate (ORR) and immune-related ORR (irORR) • To understand PK & ADA in different tumour types • To determine CLEVER-1 positivity • To assess duration of response in different tumour types • To study population PK & ADA in different tumour types • To determine CLEVER-1 positivity • To assess ORR & duration of response • To study Progression Free Survival and Overall Survival;Timepoint(s) of evaluation of this end point: • DLT is evaluated on ongoing bases for each DLT evaluable subject: DLT assessment period in Part I is 9 weeks, Part II 4 weeks after the first dose • AEs are evaluated on ongoing bases • CBR, ORR and irORR are determined by Cycle 7 (Q3W)/ by Cycle 10 (Q2W)/ by Cycle 19 (Q1W) • CLEVER-1 positivity is determined prior to IMP administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The PK profile of a single dose and repeated doses (in general and for each tumour type) • Presence of ADAs (in general and for each tumour type) • The CBR and ORR to the treatment • Duration of response • Adverse Events;Timepoint(s) of evaluation of this end point: • PK within first 5 Cycles (Q3W)/ within first 4 Cycles (Q2W)/ within first 6 Cycles (Q1W) • ADA samples periodically during treatment • CLEVER-1 positivity is determined prior to IMP administration • Duration of response and AEs are evaluated on an ongoing basis | — |
Countries
Finland, France, Germany, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs
Faron Pharmaceuticals
Outcome results
None listed