Approximately 58-68 total subjects will be enrolled. In the first stage, 10 response evaluable subjects (either IDHwt or IDHm Grade 4 astrocytoma) will be enrolled. If 1 or more of the first 10 response evaluable subjects achieve an objective response, 19 further subjects may be accrued in the second stage (for a total of 29 response evaluable subjects).
Subjects enrolling in the study will provide fresh (in subjects who undergo a planned tumor resection) or archival (all subjects) tumor tissue sample (at least 10 unstained slides of 5-micron thickness) at screening for retrospective exploratory biomarker analysis and determination of intertumoral PTGR1 levels.
STAR-001 (LP-184) will be administered via IV infusion over 30 minutes on Day 1 and Day 8 of each 21-day cycle. The STAR-001 dose for this study is 0.39 mg/kg.
Spironolactone will be administered orally on Day (-2), Day (-1), and between 4-8 hours before the STAR-001 infusion on D1 (Day of STAR-001 IV infusion) and on Day 6, Day 7, and between 4-8 hours before the STAR-001 infusion on Day 8 . The spironolactone dose for this study is 100 mg given 3 times prior to STAR-001 infusion.
Histopathology confirmed supratentorial GBM at first recurrence including both IDHwt GBM and IDHm Grade 4 astrocytoma.
Provision of archival tissue and in re-resected subjects, contemporaneous tissue.
No more than one prior systemic treatment (temozolomide + involved field radiotherapy +/- an experimental agent +/- tumor treating fields device) in IDHwt GBM
No more than one prior systemic therapy following diagnosis of IDHm Grade 4 astrocytoma
Any radiation therapy within 12 weeks prior to the first dose of study drug. unless the progression is clearly outside the radiation field (e.g., beyond the high-dose region or 80% isodose line) or there is pathologic confirmation of disease progression.
Subject has received more than 1 systemic therapy.
Subject has known hypersensitivity to STAR-001 (LP-184) or spironolactone, their components, or their excipients.
Subjects had a known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include treated basal cell or localized squamous cell skin carcinoma, localized prostate cancer, or other localized carcinomas such as carcinoma in situ of cervix, breast, or bladder.
Sequential
STAR-001 (LP-184) will be administered via IV infusion over 30 (± 5) minutes on Day 1 and Day 8 of each 21-day cycle.
DrugThe current study treatment will use STAR-001 in combination with the oral diuretic spironolactone. In preclinical tumor models, co-treatment with spironolactone (SP), a transcription-coupled nucleotide excision repair (TC-NER) inhibitor, sensitized GBM cells and xenografts to STAR-001(LP-184).
Spironolactone (drug)
DrugSpironolactone will be administered orally upon awakening taken without food on Day -2, Day -1 and Day 1 (4-8 hours prior to the STAR-001 infusion) and on Day 6, Day 7, and on Day 8.
To evaluate the safety and tolerability of STAR-001 (LP-184) when administered with spironolactone in subjects with recurrent IDHwt glioblastoma or IDHm Grade 4 astrocytoma.
Incidence and severity of adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
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