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 Phase1b trial in GBM at first recurrence is planned to further establish safety and determine potential efficacy. Upon successful completion of the Phase 1b trial, two randomized Phase 2b trials in recurrent GBM and newly diagnosed MGMT promoter unmethylated GBM will be conducted. These Phase 2b trials are to demonstrate efficacy against the current standard of care, CCNU, a nitrosourea chemotherapy, in first recurrent GBM and concurrent and adjuvant TMZ with radiotherapy in newly diagnosed MGMT promoter unmethylated GBM.

Upon determining the MTD/RP2D/DLT(dose-limiting toxicity) in Lantern Pharma's Phase 1a adult trial in advanced solid tumors will inform Starlight Therapeutics regarding the dose and schedule of STAR-001 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.