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Targeted LSAM-Cisplatin Infusion in Gliomas, Evaluation of Response

NCT07767110 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-18

No results posted yet for this study

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.

Conditions

  • Diffuse Midline Glioma (DMG)
  • Diffuse Intrinsic Pontine Glioma (DIPG)
  • Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma

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.

Sponsors & Collaborators

  • WEP Clinical

    collaborator UNKNOWN

  • NanOlogy, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07767110 on ClinicalTrials.gov