Clinical trial · Interventional
Targeted LSAM-Cisplatin Infusion in Gliomas, Evaluation of Response
Phase 1/2a Study to Determine the Safety of Intratumoral Infusion of Large Surface Area Microparticle (LSAM)-Cisplatin in Participants With Diffuse Midline Glioma (DMG), Including Diffuse Intrinsic Pontine Glioma (DIPG)
NCT07767110CI-TRIAL-00122490TIGER-1not yet recruitingPhase 1 / Phase 2ClinicalTrials.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)
Open-label, dose-escalating, Phase 1/2a trial of Large Surface Area Microparticle (LSAM)-Cisplatin to treat participants with diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), via stereotactic infusion under intraoperative magnetic resonance imaging (MRI) guidance.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Intrinsic Pontine Glioma (DIPG) | Diffuse Intrinsic Pontine Glioma | ONTOLOGY_EXACT | 0.85 |
| Diffuse Midline Glioma (DMG) | Diffuse Midline Glioma | ONTOLOGY_EXACT | 0.85 |
| Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LSAM-Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LSAM-Cisplatin 6 mg/mL
- description
- Phase 1 (Dose Escalation): Intratumoral infusion of LSAM-Cisplatin 6 mg/mL using sequential, dose escalating cohorts. Phase 2 (Dose Expansion): Intratumoral infusion of LSAM-Cisplatin 6 mg/mL at the recommended Phase 2 dose (RP2D).
- interventionNames
- Drug: LSAM-Cisplatin
Primary outcomes (1)
- measure
- Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
- timeFrame
- Day 1 to Week 24
- description
- Treatment Emergent Adverse Events will be assessed by changes in adverse events, changes in concomitant medications, changes in laboratory values, and physical exams.
Secondary outcomes (5)
- measure
- Objective Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria:
* Aged 3 to ≤ 21 years.
* Diagnosis of diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), based on characteristic magnetic resonance imaging (MRI) findings and/or histopathologic confirmation.
* Prior radiation treatment must have included focal radiation therapy per institutional standard of care and must have been initiated within 6 weeks of diagnosis.
* At least 4 weeks, but no more than 12 weeks, post-completion of radiotherapy treatment.
* A standard of care post-radiation magnetic resonance imaging (MRI) performed 4 to 6 weeks after radiation therapy is required for confirmation of eligibility.
* Performance status \[Karnofsky Performance Scale or Lansky Performance Score\] within 14 days of Day 1 ≥ 60.
* Absence of other significant medical condition.
* A legal parent/guardian and/or participant must be able to understand and be willing to sign a written informed consent and/or assent document, as appropriate.
Exclusion Criteria:
* Untreated symptomatic hydrocephalus at the time of consent, has metastatic or disseminated disease, or leptomeningeal disease.
* Magnetic resonance imaging (MRI) findings that preclude stereotactic procedure.
* Intercurrent illnesses or conditions which preclude participation: active systemic infections, autoimmune disease requiring systemic immunomodulation, active or uncontrolled seizure disorder, central nervous system (CNS) vasculopathy or aneurysms, Grade ≥3 cardiac dysfunction, Fridericia-corrected QT interval (QTcF) ≥470 ms.
* Abnormal organ function:
* Renal insufficiency: glomerular filtration rate (GFR) ≤ 60 mL/min/1.73m² (with Schwartz equation)
* Hepatic dysfunction: aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 1.5 x upper limit of normal (ULN) and 3 x upper limit of normal (ULN) in the presence of liver metastases; or bilirubin ≤ 1.5 x upper limit of normal (ULN) and 3 x upper limit of normal (ULN) in the presence of Gilbert disease
* Bone marrow suppression:
* absolute neutrophil count (ANC) \< 1,000/μL
* platelets \< 100,000/μL
* Coagulopathy or international normalized ratio (INR) \> 1.5
* Receiving any anticoagulants or antiplatelet drugs; any drugs known to cause ototoxicity and nephrotoxicity; receiving any other tumor-directed therapy.
* Known allergy or hypersensitivity to the study agent (including cisplatin and diluent components).
* Female participants of childbearing potential must not be pregnant or breast-feeding.References
Publications (0)
Data not yet available
No reference posted for this study.