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Study of LAM561 for Pediatric Malignant Glioma and Other Advanced Solid Tumors

This study is testing a drug called LAM561 in children and teenagers (up to 18 years old) who have advanced high-grade glioma (a type of brain tumor) or other solid tumors that have not responded to standard treatments or for which there is no standard treatment. The main goals are to find out how safe LAM561 is and what dose can be recommended for future studies. Patients will receive LAM561 daily in 21-day cycles, which can be repeated. The study is currently unclear on its recruitment status and plans to enroll up to 28 patients.

Study design
This is an open-label (meaning everyone knows what treatment is being given), non-randomized study. It will involve up to 28 pediatric patients and has two phases: a dose escalation phase and an expanded safety cohort.
What's involved
Participants will receive LAM561 daily in 21-day (3-week) cycles, which may be repeated continuously. Treatment may be modified or paused for up to 14 days if needed.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured between 1 to 6 cycles (each cycle is 3 weeks) of treatment.

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NCT04299191

Study of LAM561 Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors

Recruiting
PHASE1Up to 18InterventionalTreatment
Laminar Pharmaceuticals
~28 participants
Updated 2025-11-20 on ClinicalTrials.gov
What's tested:LAM561

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability of LAM561
Measured over Between 1 to 6 cycles (each cycle is 3 weeks)
+1 more outcome measured

Conditions

High-grade Glioma
Solid Tumor, Unspecified, Child

Explore related trials

Malignant GliomaSolid Neoplasm

Where it's being run

3 sites across 3 states
Arkansas1
Florida1
New Jersey1

Who to contact

Adrian Gerald McNicholl
[email protected]
+34971439886
Email the study team

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Eligibility criteria

Inclusion

Patients must be enrolled before treatment begins. Treatment must start within 14 days of study enrollment.
All clinical and laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated in the eligibility section. 4. Patients must have a Lansky or Karnofsky performance status score of ≥ 50%, corresponding to ECOG categories of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score. 5. Able to swallow and ingest oral medication or have a NG or G-tube for drug administration 6. Able to undergo adequate tumor imaging, via computerized tomography (CT) or magnetic resonance imaging (MRI) scans or any other standardized tumor assessment method based on tumor type (PET, MIBG, etc) to evaluate disease evolution 7. Adequate hematologic, renal, liver function as demonstrated by laboratory values:
ANC ≥ 1,000/ul
Hemoglobin ≥8.0 gm/dl
Platelet count ≥ 100,000/ul
Adequate Liver Function Defined As
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and
SGPT (ALT) \< 2.5 x upper limit of normal (ULN) for age. 8. Adequate Renal Function Defined As Either
Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73m2
or a serum creatinine less than or equal to the institutional normal for age 9. No history of QTc prolongation, and a normal QTc interval at screening/baseline (QTc ≤450 msec) 10. No evidence of a bleeding diathesis 11. Negative pregnancy test in women of childbearing potential within 7 days of initiating investigational therapy 12. Patient or legal guardian must give written, informed consent or assent (when applicable) - 13. Recent mothers must agree not to breast feed while receiving medications on study.

What this trial measures

  • Safety and Tolerability of LAM561Between 1 to 6 cycles (each cycle is 3 weeks)

    To determine the safety and tolerability of LAM561 in pediatric patients (under 18 years) when administered orally using a continuous dosing schedule. It will be evaluated through the adverse events \[AEs\], physical examinations and vital signs, laboratory safety tests and 12-lead electrocardiograms \[ECGs\].

  • To identify the Recommended Phase 2 Dose (RP2D) of LAM561 in pediatric patientsBetween 1 to 6 cycles (each cycle is 3 weeks)

    The RP2D of LAM561 in pediatric patients will be the Maximum Tolerated Dose during the safety cohort and it's well tolerared.