Clinical trial · Interventional
A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors
A Phase Ia Study on Tolerability and Pharmacokinetics of Irinotecan Hydrochloride Liposome Alone in Patients With Advanced Solid Tumors
- 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, dose-escalation and expansion, single centre, phase Ia study . In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection were studied in patients with advanced solid tumors, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.
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 Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan liposome | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group A
- description
- Treatment group : Irinotecan liposome
- interventionNames
- Drug: Irinotecan liposome
Primary outcomes (3)
- measure
- Adverse Event (AE)
- timeFrame
- Assessed from study inclusion to 30 days after last dose
- description
- Assessed by CTCAE 4.03
- measure
- Dose Limiting Toxicities (DLT)
- timeFrame
- DLTs will be evaluated during 21-day period following the first dose of study treatment
- description
- Dose limiting toxicities for patients in the treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed solid tumors documented as advanced or metastatic disease; 2. Subjects must be considered relapsed or refractory to standard therapies, have been intolerant to standard therapies, or have refused standard therapy; 3. ECOG: 0-1; 4. Adequate organ and bone marrow function; 5. sign an informed consent. Exclusion Criteria: 1. Patients with brain malignant tumor, lymphoma or other malignant hematologic diseases; 2. Active CNS metastasis; 3. Clinically significant GI disorders; 4. Significant cardiovascular disease; 5. Active infection or uncontrolled fever; 6. Pregnant or breast feeding patients; 7. Allergic to a drug ingredient or component; 8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
References
Publications (0)
Data not yet available