Clinical trial · Interventional
Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of ATOR-1015
A First-in-human, Multicenter, Open-label, Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of Intravenously Administered ATOR-1015
NCT03782467CI-TRIAL-00060418completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATOR-1015 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ATOR-1015
- description
- ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent.
- interventionNames
- Biological: ATOR-1015
Primary outcomes (5)
- measure
- Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- timeFrame
- From start of study until 28 days after last dose
- description
- Number of participants with treatment-related AEs assessed by CTCAE v5.0
- measure
- Safety and tolerability: Vital signs
- timeFrame
- From start of study until end of study (28-56 days after last dose)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKvarnhammar 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. PMID 30975201