Clinical trial · Interventional
Phase 1 Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of ATOR-1017
A First-in-human, Multicenter, Open-label, Phase 1 Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of Intravenously Administered ATOR-1017
NCT04144842CI-TRIAL-00065876completedPhase 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 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.
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-1017 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ATOR-1017
- description
- ATOR-1017 administered by intravenous infusions every 3 weeks until confirmed progressive disease, clear clinical deterioration, unacceptable toxicity or withdrawal of consent
- interventionNames
- Biological: ATOR-1017
Primary outcomes (2)
- measure
- Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
- timeFrame
- From start of study until 28 days after last dose
- description
- Number of participants with treatment-related AEs assessed by CTCAE v 5.0
- measure
- Safety and tolerability: Dose-limiting toxicities (DLTs)
- timeFrame
- From first dose of ATOR-1017 (Day 1) until Day 21
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSingh 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. PMID 38172595