Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATOR-1017 | Experimental | ATOR-1017 administered by intravenous infusions every 3 weeks until confirmed progressive disease, clear clinical deterioration, unacceptable toxicity or withdrawal of consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATOR-1017 | Biological | ATOR-1017 is a human monoclonal antibody targeting 4-1BB (CD137) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From start of study until 28 days after last dose |
| Safety and tolerability: Dose-limiting toxicities (DLTs) | Number of participants with DLTs | From first dose of ATOR-1017 (Day 1) until Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum observed serum concentration of ATOR-1017 (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) |
Not provided
Major Inclusion Criteria:
A patient is eligible to be included in the study if all the following criteria apply:
Major Exclusion Criteria:
A patient is excluded if any of the following criteria apply:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sumeet Ambarkhane, MD | Alligator Bioscience AB | Study Director |
| Gustav Ullenhag, Dr | Department of Oncology, Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Skåne University Hospital | Lund | SE-221 85 | Sweden | |||
| Fas 1-enheten, Centrum för Kliniska Cancerstudier, Karolinska Universitetssjukhuset |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38172595 | Derived | Singh R, Kim YH, Lee SJ, Eom HS, Choi BK. 4-1BB immunotherapy: advances and hurdles. Exp Mol Med. 2024 Feb;56(1):32-39. doi: 10.1038/s12276-023-01136-4. Epub 2024 Jan 4. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
| Immunogenicity: Anti-drug antibody (ADA) titer in serum | Levels of antibodies to ATOR-1017 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) |
| Solna |
| SE-171 64 |
| Sweden |
| Department of Oncology, Uppsala University Hospital | Uppsala | SE-751 85 | Sweden |