Glioblastoma (GBM)Phase 1/2NCT07431216
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
A Phase 1/2 study testing 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. and Spironolactone (drug) in people with Glioblastoma (GBM), run by Starlight Therapeutics Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- 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. and Spironolactone (drug)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Subjects on a stable or decreasing dose of systemic corticosteroid regimen (no increase for 7 days and dexamethasone dose or equivalent steroid dose < 4 mg/day) prior to baseline screening MRI are allowed. Exception is for subjects undergoing planned tumor resection where the dexamethasone dose may be temporarily increased and subsequently tapered as clinically indicated.
- Subject has adequate organ function, defined as follows:
- Note: Complete blood count should be obtained without transfusion or receipt of colony-stimulating factors in the 2 weeks before obtaining a sample.
- absolute neutrophil count ≥1,000/μL
- platelets ≥100,000/μL
- haemoglobin ≥ 8 g/dL
- serum creatinine clearance ≥60 mL/min
- total bilirubin ≤1.5× ULN or direct bilirubin ≤1 × ULN (exceptions are granted for patients with Gilbert's syndrome)
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN
- international normalised ratio or prothrombin time (PT) ≤1.5 × ULN unless the participant is receiving anticoagulant therapy (PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants).
- activated PTT ≤1.5 × ULN unless the participant is receiving anticoagulant therapy, if the PT or PTT is within therapeutic range of intended use of anticoagulants.
- A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP). OR b. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, from the Screening Visit through at least 180 days after the last dose of study drug and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment. Further guidance is provided in Appendix 5. Contraceptive and Barrier Guidance. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 72 hours before the first dose of study drug.
- The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- A male subject of reproductive potential is eligible to participate if he agrees to the following starting with the first dose of study drug through at least 90 days (a spermatogenesis cycle) after the last dose of study drug:
- refrain from donating sperm.
- PLUS, either:
- be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
- OR c. must agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception, as a condom may break or leak, when having sexual intercourse with a WOCBP who is not currently pregnant.
- The Investigator, or a person designated by the Investigator, will obtain written informed consent from each study participant or the participant's legally acceptable representative, when applicable, before any study-specific activity is performed. The Investigator will retain the original copy of each participant's signed consent document.
- Subject must provide archival tumor tissue sample at screening for retrospective exploratory biomarker analysis (see Laboratory Manual for tumor requirements). Subjects undergoing re-resection must also provide contemporaneous tumor sample at screening as well.
- Patients have been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
- -
Who cannot join
- 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:
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- Subjects who received colony-stimulating factors (e.g., granulocyte-colony stimulating factor, granulocyte-macrophage colony-stimulating factor, or recombinant erythropoietin) within 2 weeks prior to the first dose of study drug are not eligible.
- 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.
- Subject is currently participating and receiving an investigational agent.
- Subject has not recovered (i.e., to Grade ≤1 or to baseline) from cytotoxic therapy-induced adverse events (AEs). Note: Subjects with Grade ≤2 neuropathy, Grade ≤2 alopecia, or Grade ≤2 fatigue is an exception to this criterion and qualify for the study.
- Subject had treatment with prior systemic anticancer therapy within the 4 weeks prior to the first dose of study drug, or
- Subject has received a live vaccine within 14 days of planned start of study drug.
- Subject has clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, cardiac arrhythmia or unstable angina, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, and history of cerebrovascular accident) within 3 months prior to screening.
- Subject has heart rate-corrected QT interval prolongation >480 ms (average of triplicate ECGs) by Fredericia at screening except for a documented bundle branch block or unless secondary to pacemaker. In the case of a documented bundle branch block or a pacemaker, discussion with the medical monitor is required prior to enrolment.
- Patient is on medication that increases serum potassium (e.g., triamterene, propanolol or medications with labeled DDIs with spironolactone (e.g., digoxin).
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
Patients will continue to receive treatment based on response assessment and tolerability. Patients with disease control after Cycle 1 may continue treatment with STAR-001 (LP-184) if, in the opinion of the investigator, the patient is deriving clinical benefit from continuing study treatment. Patients may continue therapy for up to two years, or withdrawal for reasons of progressive disease on imaging, clinical progression, ≥Grade 4 AEs, withdrawal of consent, loss to follow-up, protocol violation, or at the discretion of the investigator.
Treatment beyond one year, if determined by the investigator to be of clinical benefit, requires consultation with and approval by the sponsor.
After treatment has been discontinued, an end-of-treatment visit will occur 30 days (+7 days) after the final dose. Patients are to be followed for survival (via telephone contact or review of medical records every 3 months.
- Conditions
- Glioblastoma (GBM)
- Being tested
- 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., Spironolactone (drug)
- Keywords
- recurrent GBM, rGBM
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Drug
The 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)Drug
Also called Spironolactone
Spironolactone 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.
| Study group | Role | What they receive |
|---|---|---|
| 10 subjects in the IDHwt arm | Experimental | If, among the first 10 enrolled participants in the IDHwt arm, at least 1 subject achieves an objective response, an additional 19 subjects will be enrolled in that arm.
Spironolactone is administered with each STAR-001 infusion. Receives: Drug: 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.; Drug: Spironolactone (drug) |
| 10 subjects in the IDHm Grade 4 astrocytoma arm | Experimental | If, among the first 10 enrolled participants in the IDHm Grade 4 astrocytoma arm, at least 1 subject achieves an objective response, an additional 19 subjects will be enrolled in that arm. Receives: Drug: 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.; Drug: Spironolactone (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Allowed are subjects who undergo planned tumor resection as per institutional standard of care practice. These subjects will start treatment with the combination of STAR-001 (LP-184) and spironolactone 7-20 days post-surgery. Between 10-15 subjects will enroll in each of two arms (patients with IDH wildtype \[IDHwt\] primary GBM and patients with IDH mutated \[IDHm\] Grade 4 astrocytoma) including subjects that undergo a planned tumor resection. Ten radiographically evaluable subjects in each arm are required to determine the objective response per the Simon 2-stage design. In subjects undergoing a planned tumor resection, residual tumor that is measurable by RANO 2.0 criteria are evaluable for radiographic response. Subjects not undergoing planned tumor resection must have measurable disease to enroll per RANO 2.0. 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 ac
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Starlight Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc M.D. Chamberlain, MD, Study director, Starlight Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431216
- Sponsor's protocol ID
- STAR001-GBM25-01
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07431216
- Acronym / sponsor ID
- STAR001-GBM25-01
- Conditions
- Glioblastoma (GBM)
- Keywords
- recurrent GBM, rGBM
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Starlight Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will continue to receive treatment based on response assessment and tolerability. Patients with disease control after Cycle 1 may continue treatment with STAR-001 (LP-184) if, in the opinion of the investigator, the patient is deriving clinical benefit from continuing study treatment. Patients may continue therapy for up to two years, or withdrawal for reasons of progressive disease on imaging, clinical progression, ≥Grade 4 AEs, withdrawal of consent, loss to follow-up, protocol violation, or at the discretion of the investigator.
Treatment beyond one year, if determined by the investigator to be of clinical benefit, requires consultation with and approval by the sponsor.
After treatment has been discontinued, an end-of-treatment visit will occur 30 days (+7 days) after the final dose. Patients are to be followed for survival (via telephone contact or review of medical records every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Allowed are subjects who undergo planned tumor resection as per institutional standard of care practice. These subjects will start treatment with the combination of STAR-001 (LP-184) and spironolactone 7-20 days post-surgery. Between 10-15 subjects will enroll in each of two arms (patients with IDH wildtype [IDHwt] primary GBM and patients with IDH mutated [IDHm] Grade 4 astrocytoma) including subjects that undergo a planned tumor resection. Ten radiographically evaluable subjects in each arm are required to determine the objective response per the Simon 2-stage design. In subjects undergoing a planned tumor resection, residual tumor that is measurable by RANO 2.0 criteria are evaluable for radiographic response. Subjects not undergoing planned tumor resection must have measurable disease to enroll per RANO 2.0. 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 ac
| Arm | Type | Receives |
|---|---|---|
| 10 subjects in the IDHwt arm | Experimental | Drug: 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., Drug: Spironolactone (drug)If, among the first 10 enrolled participants in the IDHwt arm, at least 1 subject achieves an objective response, an additional 19 subjects will be enrolled in that arm. Spironolactone is administered with each STAR-001 infusion. |
| 10 subjects in the IDHm Grade 4 astrocytoma arm | Experimental | Drug: 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., Drug: Spironolactone (drug)If, among the first 10 enrolled participants in the IDHm Grade 4 astrocytoma arm, at least 1 subject achieves an objective response, an additional 19 subjects will be enrolled in that arm. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.The 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). | Drug | 10 subjects in the IDHm Grade 4 astrocytoma arm, 10 subjects in the IDHwt arm |
| Spironolactone (drug)Also: SpironolactoneSpironolactone 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. | Drug | 10 subjects in the IDHm Grade 4 astrocytoma arm, 10 subjects in the IDHwt arm |
Primary outcome
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.
Time frame: 2 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Starlight Therapeutic is a precision oncology company focused solely on CNS (central nervous system) cancers, primarily brain cancers, which comprise a large and growing market globally.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc M.D. Chamberlain, MD study director
Starlight Therapeutics Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 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. and Spironolactone (drug) in people with Glioblastoma (GBM), run by Starlight Therapeutics Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Sinclair, MHA/Ed, RN (832.622.1699, sandra@lanternpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.