The MTD and recommended dose for expansion obtained from Lantern's Phase 1a trial will inform Starlight regarding dose and schedule of STAR-001. A Phase 1b/2a trial in GBM at first recurrence is planned to further establish safety, determine potential efficacy and investigate the combination of spironolactone and STAR-001. Upon successful completion of the Phase 1b/2a trial, a randomized Phase 2b trial in recurrent GBM comparing CCNU versus the combination of spironolactone and STAR-001 will be conducted. This Phase 2b trial is to demonstrate efficacy against the current standard of care, CCNU, a nitrosourea chemotherapy, in first recurrent GBM.

A Phase 1a trial in newly diagnosed unmethylated GBM is planned to further establish safety, determine potential efficacy and investigate the combination of spironolactone and STAR-001 in conjunction with standard of care radiotherapy.. The study is conducted in two parts, initial safety and tolerability will be determined when combining spironolactone and STAR-001 with involved field radiotherapy. The dose and schedule of STAR-001 will use that determined by the Lantern Phase 1 study. Upon successful completion of the Phase 1a trial, a randomized Phase 2b trial in newly diagnosed MGMT unmethylated GBM comparing temozolomide versus the combination of spironolactone and STAR-001 will be conducted. This Phase 2b trial is to demonstrate efficacy against the current standard of care, temozolomide in newly dianosed MGMT unmethylated GBM.

Upon determining the MTD/RP2D/DLT in Lantern Pharma's Phase 1a adult trial in advanced solid tumors will inform Starlight Therapeutics regarding the dose and schedule of LP-184 to commence a pediatric Phase 1a trial. The Phase 1a objective is to determine safety and potential early efficacy signals in recurrent or refractory pediatric brain cancers. The proposed dose escalation Phase 1a study will enroll diffuse midline gliomas (DMG), high grade hemispheric gliomas (HGG) and ATRT to evaluate safety, tolerability and a recommended dose for expansion of STAR-001 in pediatric brain tumors using the recommended dose for expansion from the Phase 1 adult trial. A potential pivotal Phase 2a trial for the rare and highly lethal pediatric brain cancer, including ATRT would likely follow to further assess safety, tolerability and efficacy.