None listed
Conditions
Sponsors
Faron Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Provision of signed and dated informed consent form. 2.Ability and stated willingness to comply with all study procedures and availability for the duration of the study. 3.Male or female, aged > 18 years. 4.Adequate general health (ECOG 0 or 1) to undergo planned radical surgery for renal cell or colon cancer. 5.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 Blood haemoglobin = 9.0 g/dL Creatinine clearance > 40 mL/min calculated by Cockcroft-Gault formula AST = 3 X Upper Limit of Normal (ULN) ALT = 3 X ULN Bilirubin = 1.5 X ULN Albumin = 3.0 g/dL 6.Histologically confirmed clear cell renal cell cancer planned to be treated with surgery with curative intent (Renal cell cancer cohort). In renal cell observation cohort, histological confirmation not mandatory. or Histologically confirmed adenocarcinoma of the colon planned to be treated with surgery with curative intent (Colon cancer cohort). Additional inclusion criteria for subjects planned to have a single neoadjuvant dose of CLEVER-1 antibody bexmarilimab: 7.For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 12 weeks after the end of single neoadjuvant dose of bexmarilimab administration. 8.For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 12 weeks after the administration of single neoadjuvant dose of bexmarilimab. 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 42 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1.Evidence of metastatic disease making subject not eligible for surgical resection, except for local nodal metastatic disease. 2.History of previous treatment for renal cell cancer (renal cell cancer cohorts) or colon cancer (colon cancer cohorts). 3.Less than 3 months since the last dose of any cancer therapy prior to consenting. 4.Less than 4 weeks since any major surgery. 5.Treatment with any investigational agent within 4 weeks before consenting. 6.History of another malignancy without curative treatment or suspicion of disease recurrence. 7.Evidence of severe or uncontrolled systemic diseases, congestive cardiac failure New York Heart Association (NYHA) class 2, 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. 8.Any medical condition that the Investigator considers significant to compromise the safety of the subject or that impairs the interpretation of IMP toxicity assessment. 9.Confirmed human immunodeficiency virus infection. 10.Confirmed hepatitis B or C virus infection. 11.Symptomatic cytomegalovirus infection. 12.Subjects with active autoimmune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia). 13.The subject requires systemic corticosteroid or other immunosuppressive treatment. 14.Subjects with organ transplants. 15.Subjects in dialysis. 16.Use of Live (attenuated) vaccines for 30 days prior to the start of study treatment, during treatment, and until last visit. 17.Subject is unwilling or unable to comply with treatment and trial instructions. 18.Pregnancy or lactation. 19.Medical history of chronic ulcers, abnormal liver function or previous liver problems/diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To determine the safety and tolerability of three different doses of single neoadjuvant dose of bexmarilimab for subjects with localized clear cell renal cell cancer and for subjects with colon adenocarcinoma prior radical surgery.;Secondary Objective: •To assess radiological response rate of single neoadjuvant dose of bexmarilimab •To assess pathological response rate of single neoadjuvant dose of bexmarilimab •Long-term clinical benefit of single neoadjuvant dose of bexmarilimab;Primary end point(s): •Adverse events =Grade 3 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 during the 28 days (4 weeks) following the single dose of bexmarilimab, and Surgical adverse events =Grade 3 according to the Clavien-Dindo classification occurring during the 14 days (2 weeks) following the surgery. ;Timepoint(s) of evaluation of this end point: •28 days following the administration of bexmarilimab •14 days following the surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Adverse events until the follow-up visit on Day 84 •Radiological response rate according to Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) (Day 13) •Pathological response rate evaluated with Ryan tumour regression rate (Day 14) •Long-term clinical benefit measured by disease-free survival assessed at 1, 3 and 5 years ;Timepoint(s) of evaluation of this end point: • Day 84 • Day 13 • Day 14 • At 1, 3 and 5 years | — |
Countries
Finland
Contacts
Public ContactRegulatory Affairs
Faron Pharmaceuticals Ltd
Outcome results
None listed