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NOT YET RECRUITING
NCT07767110
PHASE1/PHASE2

Targeted LSAM-Cisplatin Infusion in Gliomas, Evaluation of Response

Sponsor: NanOlogy, LLC

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

3 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-12

Completion Date

2029-12

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

DRUG

LSAM-Cisplatin

Participants with diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), will receive a single intratumoral infusion of LSAM-Cisplatin 6 mg/mL via MRI-guided delivery at an infusion rate of 5 µL/min. Phase 1 (Dose Escalation): Participants will be enrolled sequentially into one of six dose levels. Volumes being delivered will range from 27 to 296 µL over a time period of 5 to 59 minutes. Phase 2 (Dose Expansion): Participants will receive LSAM-Cisplatin 6 mg/mL at the recommended Phase 2 dose (RP2D) selected based on the safety and tolerability findings from the dose-escalation phase.