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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATOR-1015 | Experimental | ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATOR-1015 | Biological | Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | 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. | 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. | From start of study until end of study (28-56 days after last dose) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malin Carlsson, MD | Alligator Bioscience AB | Study Director |
| Jeffrey Yachnin, Dr | Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase 1 Unit, Department of Oncology, Rigshospitalet | Copenhagen | DK-2100 | Denmark | |||
| Center for Cancer Research, Department of Oncology, Herlev Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30975201 | Derived | Kvarnhammar AM, Veitonmaki N, Hagerbrand K, Dahlman A, Smith KE, Fritzell S, von Schantz L, Thagesson M, Werchau D, Smedenfors K, Johansson M, Rosen A, Aberg I, Winnerstam M, Nyblom E, Barchan K, Furebring C, Norlen P, Ellmark P. The CTLA-4 x OX40 bispecific antibody ATOR-1015 induces anti-tumor effects through tumor-directed immune activation. J Immunother Cancer. 2019 Apr 11;7(1):103. doi: 10.1186/s40425-019-0570-8. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 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 | Levels of antibodies to ATOR-1015 will be evaluated | 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 | From start of study until end of study (28-56 days after last dose) |
| Herlev |
| DK-2730 |
| Denmark |
| Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus | Lund | SE-221 85 | Sweden |
| Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset | Solna | SE-171 64 | Sweden |
| Onkologavdelningen, Akademiska Sjukhuset | Uppsala | SE-751 85 | Sweden |