A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Objective Response of STAR-001 … (NCT07431216) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Objective Response of STAR-001 (LP-184) in Combination With Spironolactone in Supratentorial Glioblastoma at First Progression
68 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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
✓. Radiographically measurable disease that can be assessed per RANO 2.0.
✓. Subjects are ≥ 18 and \< 70 years old at the time of informed consent with a diagnosis of progressive or recurrent GBM by MRI findings.
✓. Up to 5 subjects in each Simon stage have a clinically indicated need for surgical intervention per institutional standard of care.
✓. Performance status must be ≥ 70% on the Karnofsky scale within 14 days prior to enrolment.
Exclusion criteria
What they're measuring
1
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.
. 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.
✕. Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection that requires systemic therapy. Specific examples include, but are not limited to, history of (non-infectious) pneumonitis that required steroids or current pneumonitis, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining consent).
✕. Subject has a condition (such as transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the subject's participation for the full duration of the study treatment including the following:
✕. Subject has a known history of HIV (type 1 or 2 antibodies).
✕. Subject has known active hepatitis B (e.g., hepatitis B surface antigen reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid \[qualitative\] is detected). Subjects with treated hepatitis C are permitted.