OncoMatch/Clinical Trials/NCT04299191
Study of LAM561 Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors
Is NCT04299191 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies LAM561 for high-grade glioma.
Treatment: LAM561 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Tumor Agnostic
Lab requirements
Blood counts
ANC ≥ 1,000/ul; Hemoglobin ≥8.0 gm/dl; Platelet count ≥ 100,000/ul
Kidney function
Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73m2 or a serum creatinine ≤ institutional normal for age
Liver function
Total bilirubin ≤ 1.5 x ULN for age; SGPT (ALT) < 2.5 x ULN for age
Cardiac function
No history of QTc prolongation, and a normal QTc interval at screening/baseline (QTc ≤450 msec)
Adequate hematologic, renal, liver function as demonstrated by laboratory values; No history of QTc prolongation, and a normal QTc interval at screening/baseline (QTc ≤450 msec)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arkansas Children's Research Institute · Little Rock, Arkansas
- University of Miami Hospital · Miami, Florida
- Hackensack Meridian Health, Inc · Edison, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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