Neoplasms, Solid Tumor
Conditions
Brief summary
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.
Interventions
BIOLOGICALATOR-1015
Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)
Sponsors
Alligator Bioscience AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Major Inclusion Criteria: * Diagnosis of advanced and/or refractory solid malignancy * Eastern Cooperation Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of at least 3 months Major
Exclusion criteria
* Organ transplant recipient * Active autoimmune disorder * Other malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability: Clinical laboratory tests | From start of study until end of study (28-56 days after last dose) | Clinical laboratory tests include clinical chemistry, hematology, coagulation, hormones and urinalysis. |
| Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | From start of study until 28 days after last dose | Number of participants with treatment-related AEs assessed by CTCAE v5.0 |
| Safety and tolerability: Vital signs | From start of study until end of study (28-56 days after last dose) | Vital signs include blood pressure, pulse rate, oxygen saturation and body temperature. Clinically significant abnormal findings will be reported as AEs. |
| Safety and tolerability: Physical examination | From start of study until end of study (28-56 days after last dose) | 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. |
| Safety and tolerability: 12-lead electrocardiogram (ECG) | From start of study until end of study (28-56 days after last dose) | Clinically significant abnormal ECG findings will be reported as AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Maximum observed serum concentration of ATOR-1015 (Cmax) | From start of study until end of study (28-56 days after last dose) | — |
| Pharmacokinetics: Time to Cmax | 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) | From start of study until end of study (28-56 days after last dose) | — |
| Immunogenicity: Anti-drug antibody (ADA) titer in serum | From start of study until end of study (28-56 days after last dose) | Levels of antibodies to ATOR-1015 will be evaluated |
| Clinical efficacy: Anti-tumor activity assessed by response evaluation criteria in solid tumors for immune-based therapeutics (iRECIST) | From start of study until end of study (28-56 days after last dose) | Computed tomography (CT) scans of tumors will be evaluated according to iRECIST |
Countries
Denmark, Sweden
Outcome results
None listed