The multicentre, single-arm study is designed to evaluate the tolerability and safety of escalating doses of LP-184 in patients with advanced solid tumours and recurrent high-grade gliomas including glioblastoma.
It will also determine the maximum tolerated dose and the recommended Phase II dose, which the company will use in its further studies.
A total of 35 patients will receive an LP-184 infusion on days one and eight of each 21-day cycle, for at least two cycles.
They will be monitored to assess the drug candidate’s clinical activity, safety and pharmacokinetics.
Lantern president and CEO Panna Sharma said: “Insights from our proprietary AI and machine learning platform, RADR, were instrumental in our development of LP-184 and aided in understanding its mechanism of action, identifying and prioritising its cancer indications, and generating machine learning biomarker signatures to assist with patient selection in future clinical trials.
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“The rapid advancement of LP-184 into a first-in-human Phase I trial underscores the immense potential that we see in this drug candidate, as well as for our approach to AI-enabled drug development.”
Lantern plans to enrol a minimum of three patient cohorts for dose escalation.
The company has so far activated two trial sites and plans to activate multiple additional sites in the US over the next 100 days.
Phase Ia of the trial is expected to be completed in the first half of next year.
Once the first phase has been completed, Lantern plans to begin other clinical trials of LP-184 for treating multiple solid tumour indications.
Company subsidiary Starlight Therapeutics will develop the drug for brain and central nervous system indications under the name STAR-001.