Bexmarilimab treatment has demonstrated tolerable safety profile and anticancer efficacy in some subjects with advanced malignancies. This is the first study to investigate the effect of single neoadjuvant dose of anti-CLEVER-1 antibody bexmarilimab prior to radical surgery of renal cell and colon cancers. We expect that the single dose will demonstrate measurable effects on the tumour immunological microenvironment as well as systemic effects on subject´s immunological status and that this evidence may be used to guide future neoadjuvant studies. There will be a dose escalation to investigate the effect of different doses of bexmarilimab. In addition to subjects receiving single neoadjuvant dose of bexmarilimab, there will be an observational cohort without Investigational Medicinal Product (IMP) for either cancer. All patients participating in the study (whether in investigational or observational cohort) will attend each visit and are assessed for the same endpoints.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
A single neoadjuvant dose will be administered prior to surgery.
Turku University Hospital
Turku, Finland
Adverse Events ≥Grade 3 during the 28 days (4 weeks) following the single dose of bexmarilimab and surgical adverse events ≥Grade 3 during the 14days (2 weeks) following the surgery
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
Time frame: 28 days and 14 days
Adverse events until the follow-up visit on Day 84
Time frame: Day 84
Radiological response rate according to the response evaluation criteria in solid tumours (RECIST 1.1) (Day 13)
Time frame: Day 13
Pathological response rate evaluated with Ryan tumour regression grade (Day 14), percentage of tumour cell necrosis
Time frame: Day 14
Long-term clinical benefit measured by disease-free survival assessed at 1, 3 and 5 years
Time frame: 1, 3, and 5 years
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