The aim of the study is to assess the safety and tolerability of increasing doses of ATOR-1017 when administered as repeated intravenous infusions to patients with advanced and/or refractory solid malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
ATOR-1017 is a human monoclonal antibody targeting 4-1BB (CD137)
Department of Oncology, Skåne University Hospital
Lund, Sweden
Fas 1-enheten, Centrum för Kliniska Cancerstudier, Karolinska Universitetssjukhuset
Solna, Sweden
Department of Oncology, Uppsala University Hospital
Uppsala, Sweden
Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
Number of participants with treatment-related AEs assessed by CTCAE v 5.0
Time frame: From start of study until 28 days after last dose
Safety and tolerability: Dose-limiting toxicities (DLTs)
Number of participants with DLTs
Time frame: From first dose of ATOR-1017 (Day 1) until Day 21
Pharmacokinetics: Maximum observed serum concentration of ATOR-1017 (Cmax)
Time frame: From start of study until end of study (28-56 days after last dose)
Pharmacokinetics: Time to Cmax
Time frame: From start of study until end of study (28-56 days after last dose)
Pharmacokinetics: Area under the ATOR-1017 serum concentration-time curve (AUC)
Time frame: From start of study until end of study (28-56 days after last dose)
Immunogenicity: Anti-drug antibody (ADA) titer in serum
Levels of antibodies to ATOR-1017 will be evaluated
Time frame: From start of study until end of study (28-56 days after last dose)
Clinical efficacy: Anti-tumor activity assessed by response evaluation criteria in solid tumors for immune-based therapeutics (iRECIST)
Computed tomography (CT) scans of tumors will be evaluated according to iRECIST
Time frame: From start of study until end of study (28-56 days after last dose)
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