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LAM561 · 1 trial · 2 indications
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 \[ECGs\].
The RP2D of LAM561 in pediatric patients will be the Maximum Tolerated Dose during the safety cohort and it's well tolerared.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | The dose level corresponds to 80% of the maximum tolerated dose of LAM561 in adult patients when adjusted for body surface area. The escalation will be to the 100%, and 120% of the maximum tolerated dose of LAM561 in adult patients when adjusted for body surface area. Dose escalation decisions will be made by all active Investigators in collaboration with the Medical Monitor when at least three patients have completed the DLT observation period (Cycle 1) at each dose level. When the third patient at any given dose level has received 14 days of therapy, an "escalation teleconference" will be scheduled after that patient has completed the DLT observation period (Cycle 1). The decision to progress to the next dose level will be made on the basis of review of all significant LAM561-related toxicities. |
| Name | Type | Description |
|---|---|---|
| LAM561 | DRUG | Once a patient is allocated a dose of LAM561, they will receive the same dose on a daily basis in treatment cycles of 21 days (3 weeks), which may be repeated without therapy interruption until a criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another "general" criterion) is met. The starting dose will be 2.8 g/m2 twice daily. If tolerated, doses will be escalated to 3.5 g/m2 twice daily and then to a third dose level of 4.2 g/m2 twice daily. These dose levels correspond to 80%, 100%, and 120% of the maximum tolerated dose of LAM561 in adult patients when adjusted for body surface area. A total of 3 dose cohorts are anticipated for the dose escalation phase of the study, with up to 6 patients enrolled at each dose level according to a standard "3+3" design. During each dose cohort, at least 1 week must elapse between the first and subsequent patients receiving treatment with LAM561. |
Inclusion Criteria: 1. Age \<18 years 2. Diagnosis: Patients must have a histologically- or cytologically-confirmed advanced solid malignancy that is progressive, recurrent or refractory to standard-of-care treatment, or for which there is no standard therapy. Examples of tumors that lack a standar...
LAM561 is an investigational small molecule being studied for the treatment of high-grade glioma, a type of malignant brain tumor. It is also being evaluated in pediatric patients with other advanced solid tumors. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.
LAM561 is a small molecule being developed for oncology. The specific molecular target of LAM561 has not been disclosed in the available information. The drug is being studied in biomarker-selected patients, indicating that certain genetic or molecular markers may be used to identify patients who could benefit from treatment.
LAM561 is being developed by Meridian Bioscience Inc, a company traded on the NASDAQ under the ticker symbol VIVO. The company is conducting a Phase 1 clinical trial of LAM561 in pediatric patients with malignant glioma and other advanced solid tumors.
LAM561 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting participants and is designed to evaluate the safety and tolerability of LAM561 in pediatric patients with high-grade glioma and other advanced solid tumors.
LAM561 is being studied in one active clinical trial with the identifier NCT04299191. This Phase 1 trial is titled 'Study of LAM561 Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors' and is recruiting participants in the United States. The trial is uncontrolled and not randomized or double-blinded.
Yes, LAM561 is also referred to as LAM561 acid in the clinical trial context. The ongoing Phase 1 trial NCT04299191 specifically studies 'LAM561 Acid' in pediatric patients with malignant glioma and other advanced solid tumors. Both names refer to the same investigational drug.