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
8 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
Researchers are studying LAM561 acid in children with malignant glioma and other advanced solid tumors that are progressive, recurrent, or resistant to standard treatments. This open-label, non-randomized clinical trial aims to find the safest dose and evaluate the safety and tolerability of LAM561, as well as identify the recommended dose for further studies. The study includes patients under 18 years with confirmed advanced solid tumors or certain brain tumors, without prioritizing tumor types within enrollment. Participants will receive LAM561 orally in daily doses during treatment cycles lasting 21 days, repeated continuously until disease progression, unacceptable side effects, or other criteria require stopping treatment. The dose may start at 2.8 g/m2 twice daily and may be increased in steps up to 4.2 g/m2 twice daily, adjusted for body surface area. Treatment interruptions, dose reductions, or intermittent dosing schedules may be used if needed due to side effects. The study has a dose escalation phase followed by an expanded safety group to confirm the recommended dose. During the study, patients will undergo regular safety monitoring, laboratory tests, and tumor imaging to assess treatment effects. Investigators will evaluate how well patients tolerate the drug and monitor for any toxicities. Pharmacokinetic profiles will be characterized during the first two cycles, and anti-tumor effects will be assessed every 12 weeks. Patients may receive 1 to 6 cycles of treatment, with the possibility of extension if benefits are seen. Those benefiting may continue treatment through compassionate use after the study ends.
CONDITIONS
Brief 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...
- Patient is younger than 18 years old
- Histologically or cytologically confirmed advanced solid malignancy that is progressive, recurrent, or refractory to standard treatment, or diagnosed by imaging for certain brain tumors
- Enrollment before treatment begins and treatment starts within 14 days of enrollment
- Performance status score of 50% or higher (Lansky or Karnofsky scale)
- Able to swallow oral medication or have a feeding tube for drug administration
- Able to undergo tumor imaging to evaluate disease
- Adequate blood counts and organ function as specified
- Normal QTc interval and no bleeding disorders
- Negative pregnancy test for females of childbearing potential
- Written informed consent or assent provided
- Agreement not to breastfeed during study treatment
You will not qualify if you...
- Age 18 years or older
- Known allergy to any component of LAM561
- Use of other investigational drugs recently
- Significant toxicities from previous chemotherapy or radiotherapy
- Recent surgery within 14 days (except shunt or line insertion)
- Significant intracranial or intratumoral hemorrhage within the last month
- Uncontrolled cardiovascular disease or recent heart problems
- Gastrointestinal conditions affecting drug absorption
- Inability to take oral medications due to vomiting
- Uncontrolled hyperlipidemia or lipid-lowering therapy
- Severe uncontrolled medical diseases or infections
- Need for certain medications like warfarin or phenytoin
- Serious unstable medical or psychiatric conditions
- Pregnancy or breastfeeding
- Lack of agreement to use effective contraception for 6 months after therapy completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Between 3 to 18 weeks (1 to 6 cycles), with possible extension if beneficial
Participants receive daily doses of LAM561 in 21-day treatment cycles. Treatment continues without interruption until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Dose adjustments or treatment breaks may occur as needed.
Visits during cycles 1 and 2 on Days 1, 8, and 15, and additional visits every cycle as needed
Duration - 30 days after last dose
Participants are monitored after treatment ends to assess safety and LAM561 pharmacokinetics 30 days after the last dose.
1 visit (in-person) at 30 days post-treatment
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
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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