Neoplasms, Solid Tumor
Conditions
Brief summary
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.
Interventions
BIOLOGICALATOR-1017
ATOR-1017 is a human monoclonal antibody targeting 4-1BB (CD137)
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: A patient is eligible to be included in the study if all the following criteria apply: * Has a diagnosis of advanced and/or refractory solid malignancy (histologically or cytologically documented) * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Has a minimum of one measurable tumor lesion * Has acceptable hematologic and clinical chemistry laboratory values Major
Exclusion criteria
A patient is excluded if any of the following criteria apply: * Has not recovered from AEs to at least grade 1 by CTCAE version 5.0 due to prior anti-cancer medications * Has symptomatic, steroid-dependent or progressive brain metastasis/metastases * Has a history of another primary malignancy, except for: a) Malignancy treated with curative intent and with no known active disease within 2 years prior to first dose of ATOR-1017, b) Adequately treated non-invasive basal skin cancer or squamous cell skin carcinoma, c) Adequately treated uterine cervical cancer stage 1B or less * Has an autoimmune disorder requiring immune modulating treatment during the last 2 years * Receives treatment with systemic immunosuppressant medication (except for inhaled and low dose systemic corticosteroids, i.e. ≤10 mg prednisolone or equivalent per day) * Is a female patient who is pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 | From start of study until 28 days after last dose | Number of participants with treatment-related AEs assessed by CTCAE v 5.0 |
| Safety and tolerability: Dose-limiting toxicities (DLTs) | From first dose of ATOR-1017 (Day 1) until Day 21 | Number of participants with DLTs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Area under the ATOR-1017 serum concentration-time curve (AUC) | From start of study until end of study (28-56 days after last dose) | — |
| Pharmacokinetics: Maximum observed serum concentration of ATOR-1017 (Cmax) | 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) | 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 |
| 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-1017 will be evaluated |
| Pharmacokinetics: Time to Cmax | From start of study until end of study (28-56 days after last dose) | — |
Countries
Sweden
Outcome results
None listed