Lantern Pharma Inc. announced the dosing of the first patient in the Phase 1 clinical trial evaluating Lantern?s investigational new drug LP-184 in patients with advanced solid tumors. The single arm multicenter Phase 1 trial (NCT05933265) is assessing the safety and tolerability of escalating doses of LP-184 to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) in patients with advanced solid tumors and recurrent high-grade gliomas, including glioblastoma (GBM). The study has been designed as a 35 patient trial with patients receiving LP-184 infusion on Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles.

Patients will be monitored for safety, pharmacokinetics, and clinical activity, and dose escalation is planned with minimum of three patient cohorts. Lantern has already activated two clinical trial sites and plans to activate multiple additional sites in the US over the next 100 days. Lantern anticipates the Phase 1A portion of the trial to be completed in the first half of 2024.

After the Phase 1 trial is completed, Lantern plans to advance LP-184 into additional clinical trials for multiple solid tumor indications, and Lantern?s subsidiary, Starlight Therapeutics, will advance the clinical development of LP-184 for all brain and CNS indications under the name STAR-001. Globally, the aggregate annual market potential of LP-184/STAR-001?s programs is estimated to be approximately $11-13 billion, consisting of $6-7 billion for solid tumors and $5-6 billion for CNS cancers.