Clinical trial · Interventional
Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour
Phase 1 Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour
NCT01058616CI-TRIAL-00009406completedPhase 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 study will evaluate the safety profile for LTX-315 a lytic-peptide that has shown effect in animal models to kill cancer tumours when injected directly in to the tumour. The study will also monitor the immunological response in the body after injection of LTX-315.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer With Transdermal Accessible Tumour | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LTX-315 (Oncopore™) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluate safety profile of LTX-315 by assessment of adverse events and abnormal laboratory values recorded during the study. Necrosis of the target tumour based on imaging and core biopsy analysis.
- timeFrame
- 12 weeks
Secondary outcomes (3)
- measure
- Assessment of the anti-tumour activity: Objective response in the target tumour, response in non-target tumours, Immunological response.
- timeFrame
- 12 weeks
- measure
- Core biopsy staining for lymphocyte infiltratio
- timeFrame
- 12 weeks
- measure
- Tumour volume measurment
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed malignant tumour. Transdermally accessible lesion (in or close to the skin) of 1 - 5 cm in diameter. * ECOG Performance status (PS): 0 - 2 * Life expectancy: At least 3 months
References
Publications (0)
Data not yet available
No reference posted for this study.