Actively Recruiting
Study of LAM561 Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors
Led by Laminar Pharmaceuticals · Updated on 2025-11-20
28
Participants Needed
3
Research Sites
326 weeks
Total Duration
On this page
Sponsors
L
Laminar Pharmaceuticals
Lead Sponsor
H
Hackensack Meridian Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
An open label, non-randomized study in pediatric patients with advanced high-grade gliomas and other solid tumors. The study will be performed in two phases: a dose escalation phase in up to 18 patients following a standard "3+3" design to establish dose-limiting toxicity (DLT) and a "safe" dose of LAM561 followed by an expanded safety cohort of up to 10 patients treated at the Maximum Tolerated Dose (MTD). If the MTD is well tolerated in the expanded safety cohort, that dose becomes the Recommended Phase 2 Dose (RP2D). Glioma patients and other solid tumor patients (including non-glial brain tumors) will be treated as a single cohort. Patients with either tumor type will be allowed to enroll on the study as positions are made available. No tumor type will be given priority over another and there is no minimum number of glioma patients or solid tumor patients that must be enrolled on the trial.
CONDITIONS
Official Title
Study of LAM561 Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Under 18 years old
- Histologically or cytologically confirmed advanced solid malignancy that is progressive, recurrent, refractory to standard treatment, or without standard therapy
- Radiographic diagnosis allowed for diffuse midline glioma or diffuse intrinsic pontine glioma without histologic confirmation
- Enrolled before treatment begins and treatment starts within 14 days of enrollment
- All clinical and laboratory eligibility studies performed within 7 days prior to enrollment
- Lansky or Karnofsky performance status score of 50% or higher (Karnofsky for >16 years, Lansky for 3 16 years)
- Able to swallow oral medication or have a feeding tube for drug administration
- Able to undergo adequate tumor imaging to evaluate disease
- Adequate blood counts: ANC 3 1,000/ul, Hemoglobin 3 8.0 gm/dl, Platelets 3 100,000/ul
- Adequate liver function: total bilirubin 4 1.5 x age-adjusted upper limit, ALT < 2.5 x age-adjusted upper limit
- Adequate renal function: creatinine clearance or GFR 3 70 ml/min/1.73m2 or serum creatinine within normal for age
- No history of QTc prolongation and normal QTc interval at screening (QTc 450 msec)
- No evidence of bleeding disorders
- Negative pregnancy test for women of childbearing potential within 7 days before starting therapy
- Written informed consent or assent provided
- Recent mothers agree not to breastfeed during study treatment
You will not qualify if you...
- 18 years of age or older
- Known allergy to any component of the study drug
- Use of other investigational drugs within five half-lives before first dose of LAM561
- Prior chemotherapy or radiotherapy toxicities above Grade 1 that affect safety assessment
- Surgery within 14 days prior to first dose (except shunt or line insertion)
- Known Grade >1 intracranial or intratumoral hemorrhage within past month (except resolving or minor hemorrhage)
- Significant or uncontrolled cardiovascular disease including severe heart failure or recent heart attack
- Impaired gastrointestinal function affecting drug absorption
- Inability to take oral medications due to uncontrolled vomiting
- History of uncontrolled high lipid levels or need for lipid-lowering therapy
- Severe or uncontrolled other medical diseases that could affect participation
- Need for warfarin, phenytoin, or certain sulphonylurea drugs
- Serious or unstable medical, psychiatric, or other conditions interfering with safety or compliance
- Pregnant females
- Lactating females who do not agree to stop breastfeeding
- Males and females of reproductive potential not agreeing to effective contraception during and 6 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Arkansas Children's Research Institute
Little Rock, Arkansas, United States, 72202
Actively Recruiting
2
University of Miami Hospital
Miami, Florida, United States, 33146
Actively Recruiting
3
Hackensack Meridian Health, Inc
Edison, New Jersey, United States, 08837
Actively Recruiting
Research Team
A
Adrian Gerald McNicholl
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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