Clinical trial · Interventional
A Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours
Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours
NCT01281592CI-TRIAL-00013858completedPhase 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)
This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
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 |
|---|---|---|---|
| Advanced or Metastatic Solid Tumours | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LOR-253 HCl | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LOR-253 HCl
- description
- LOR-253 HCl will be given in ascending doses until the maximum administered dose or appropriate target dose is reached. A biomarker study of up to 10 patients will be conducted upon achieving appropriate dose level.
- interventionNames
- Drug: LOR-253 HCl
Primary outcomes (1)
- measure
- To determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
- timeFrame
- 8 weeks
Secondary outcomes (1)
- measure
- To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours.
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female 18 years of age or older. 2. Histologically confirmed diagnosis of solid tumour for which no effective therapy is available or that is unresponsive to conventional therapy. 3. Meet laboratory parameter requirements at study entry. Exclusion Criteria: 1. Chemotherapy, radiotherapy, biologic therapy, immunotherapy or any other investigational drugs within 21 days of beginning study treatment with LOR-253 HCl. 2. A hematologic malignancy. 3. A history of brain or other central nervous system metastases. 4. Have a presence of a significant infection. 5. Clinically significant autoimmune disease. 6. Uncontrolled intercurrent illness. 7. With iron or copper overload syndromes. 8. Pregnancy or breast feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.