The aim of the study is to investigate the safety and tolerability of ATOR-1015 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
33
Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)
Phase 1 Unit, Department of Oncology, Rigshospitalet
Copenhagen, Denmark
Center for Cancer Research, Department of Oncology, Herlev Hospital
Herlev, Denmark
Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus
Lund, Sweden
Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset
Solna, Sweden
Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Number of participants with treatment-related AEs assessed by CTCAE v5.0
Time frame: From start of study until 28 days after last dose
Safety and tolerability: Vital signs
Vital signs include blood pressure, pulse rate, oxygen saturation and body temperature. Clinically significant abnormal findings will be reported as AEs.
Time frame: From start of study until end of study (28-56 days after last dose)
Safety and tolerability: Physical examination
Physical examination will as a minimum include examination of mouth, throat, lymph nodes, respiratory, cardiovascular system, abdomen, extremities, neurological system and skin. Clinically significant abnormal findings will be reported as AEs.
Time frame: From start of study until end of study (28-56 days after last dose)
Safety and tolerability: 12-lead electrocardiogram (ECG)
Clinically significant abnormal ECG findings will be reported as AEs.
Time frame: From start of study until end of study (28-56 days after last dose)
Safety and tolerability: Clinical laboratory tests
Clinical laboratory tests include clinical chemistry, hematology, coagulation, hormones and urinalysis.
Time frame: From start of study until end of study (28-56 days after last dose)
Pharmacokinetics: Maximum observed serum concentration of ATOR-1015 (Cmax)
Time frame: From start of study until end of study (28-56 days after last dose)
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Onkologavdelningen, Akademiska Sjukhuset
Uppsala, Sweden
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-1015 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-1015 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)