The US Food and Drug Administration (FDA) has cleared Starlight Therapeutics' investigational new drug application (IND) for a Phase Ib/IIa trial assessing the combination of STAR-001 (LP-184) and spironolactone to treat glioblastoma multiforme (GBM) at first progression.
Starlight Therapeutics is a subsidiary of Lantern Pharma.
The upcoming trial aims to assess the tolerability, preliminary efficacy, and safety of the combination therapy in individuals with recurrent GBM.
A Phase Ia trial is currently in progress to determine dosing, safety, and the maximum tolerated dose across various solid tumours, including GBM. Enrolment is anticipated to conclude this quarter.
This study aims to help in determining baseline dosing levels and anticipated drug concentration levels in the tumour and blood plasma. This will inform subsequent clinical trials, including those planned by Starlight.
Starlight is planning to initiate the Phase Ib/IIa trial between late 2025 and early 2026, pending additional financing.
Regular updates on study preparation, subject enrolment, and preliminary data will be provided once available, stated the company.
Starlight Therapeutics' chief medical officer Dr Marc Chamberlain said: "This FDA clearance represents a significant milestone for Starlight Therapeutics and our mission to bring innovative treatment options to patients facing the most challenging forms of brain and central nervous system (CNS) cancers.
"We believe our unique combination approach has the potential to offer new hope for patients and their families while advancing a novel mechanism to challenge these recurrent brain cancers."
STAR-001 is said to be a brain-penetrant, synthetically lethal, DNA-damaging agent, and claims to have shown potential in preclinical studies targeting various solid tumours, which include adult and paediatric brain cancers.
Lantern Pharma has secured fast-track and orphan drug designations from the US regulator for STAR-001 in GBM, which is an aggressive form of brain cancer.
Starlight Therapeutics uses Lantern's AI drug development platform and focuses on advancing therapeutic combinations for brain and CNS cancers in both adult and paediatric subjects.
Lantern Pharma recently completed targeted enrolment for its multi-centre Phase II HARMONIC trial of LP-300 in Japan, aimed at treating non-small cell lung cancer.
"FDA clears Starlight Therapeutics' IND for Phase Ib/IIa glioblastoma trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.