Targeted LSAM-Cisplatin Infusion in Gliomas, Evaluation of Response (TIGER-1)

August 14, 2026 updated by: NanOlogy, LLC

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Large Surface Area Microparticle (LSAM)-Cisplatin consists of large surface area microparticles of the chemotherapy drug cisplatin. These microparticles are administered as a single-magnetic resonance imaging (MRI) guided infusion directly into the tumor to target cancer at the site of the disease with less systemic exposure than intravenously administered chemotherapy. In this study, all participants with diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), will receive LSAM-Cisplatin and will be evaluated to determine whether it is safe and has an effect on the tumor.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LSAM-Cisplatin 6 mg/mL

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).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
Time Frame: Day 1 to Week 24
Treatment Emergent Adverse Events will be assessed by changes in adverse events, changes in concomitant medications, changes in laboratory values, and physical exams.
Day 1 to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Day 1 to Week 24
Overall survival (OS) as determined by survival time post-infusion of LSAM-Cisplatin.
Day 1 to Week 24
Objective Response Rate (ORR)
Time Frame: Weeks 4, 12, and 24
The proportion of participants with overall confirmed response of complete response (CR) or partial response (PR) as determined using Response Assessment in Pediatric Neuro-Oncology (RAPNO)/Response Assessment in Pediatric Neuro-Oncology for Diffuse Intrinsic Pontine Glioma (RAPNO-DIPG) criteria.
Weeks 4, 12, and 24
Progression-Free Survival (PFS)
Time Frame: Day 1 to Week 24
Progression-Free survival (PFS) as assessed using Response Assessment in Pediatric Neuro-Oncology (RAPNO)/Response Assessment in Pediatric Neuro-Oncology for Diffuse Intrinsic Pontine Glioma (RAPNO-DIPG) criteria.
Day 1 to Week 24
Concentration of Cisplatin in the Systemic Circulation Post-infusion
Time Frame: Day 1 to Week 8
Cisplatin concentrations in plasma samples collected pre-infusion of LSAM-Cisplatin, and at 1, 2, 24, and 48 hours after completion of the LSAM-Cisplatin infusion, and at Weeks 1, 2, 3, 4, and 8.
Day 1 to Week 8
Concentration of Cisplatin in the Cerebrospinal Fluid (CSF) Post-infusion
Time Frame: Prior to infusion to Week 24
Cisplatin concentrations in cerebrospinal fluid (CSF) samples collected prior to infusion of LSAM-Cisplatin, prior to discharge from the hospital post-infusion; and at Weeks 4, 12, and 24.
Prior to infusion to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NanOlogy, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
WEP Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LSAMCIS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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