Acute Ischemic StrokePhase 2STARSNCT05363397
Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
A Phase 2 study testing TBO-309 in people with Acute Ischemic Stroke, run by The Florey Institute of Neuroscience and Mental Health at 7 sites in Australia.
Trial summary
STARS is a prospective, multicentre, open-label, dose escalation, Phase IIa study to assess the safety and tolerability of TBO-309, an adjuvant antiplatelet therapy, in patients with AIS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- TBO-309
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 7 sitesAustralia
- Study dates
- 27 Sep 2023to 1 May 2026
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or more
- Patient has an acute ischaemic stroke
- Patient will be treated with either:
- Intravenous thrombolysis (IVT) with alteplase or tenecteplase for a diagnosis of AIS that is confirmed by CT imaging;
- alone/OR WITH
- Endovascular Thrombectomy (EVT) for large vessel occlusion (LVO) in the internal carotid artery, middle cerebral artery (M1 segment), middle cerebral artery (M2 segment) or with tandem occlusion of both the cervical carotid and intracranial large arteries who either:
Show all 11Show fewer
- presented within 6 hours of stroke onset
- OR
- presented between 6-24 hours after they were last known to be well and clinical observations and either CT perfusion or MRI features indicate the presence of salvageable brain tissue, defined as ischaemic core <70mL with a mismatch ratio >1.8 and absolute mismatch >15mL.
- Patient has at least a mild grade of neurological impairment i.e. NIHSS of 5 or more
- Patient has an estimated pre-stroke mRS of less than 4
Who cannot join
- Patient is considered unlikely to benefit from study intervention defined by one of the following:
- Advanced dementia
- Severe pre-stroke disability (mRS score 4-5)
- Glasgow Coma Score (GCS) 3 to 5
- Evidence of a large well-defined ischaemic lesion measuring more than one third of the MCA territory
- High likelihood of undergoing stent insertion and requiring additional antithrombotic(s)
Show all 21Show fewer
- Uncontrolled hypertension (SBP >180 or DBP >110, refractory to medical therapy)
- ICH within the last 90 days
- Myocardial infarction or stroke within the last 30 days
- Patient has an underlying disease process with a life expectancy of <90 days
- Contraindication to thrombolysis i.e. increased bleeding risk
- Contraindication to intravenous contrast agents including renal impairment or allergy
- Known treatment with dual antiplatelet therapy or anticoagulant medication
- Known severe liver disease
- Known bleeding disorder
- Cardiopulmonary resuscitation or arterial puncture at non-compressible site or lumbar puncture within 7 days
- Another medical illness or social circumstance that may interfere with outcome assessments and follow-up
- Known or suspected pregnancy
- Patients currently participating in another interventional clinical trial
- Informed consent unable to be obtained from the patient or their Person Responsible/Medical Treatment Decision Maker prior to study interventions
- Study drug cannot be given within one hour of thrombolytic drug bolus
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Australia7 sites, 7 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Tim Kleinig, Professor, Timothy.Kleinig@sa.gov.au
Tim Kleinig, Professor
- Recruiting
Eastern Health- Box Hill Hospital
Box Hill, Victoria, 3128
Philip Choi, Philip.choi@monash.edu
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Timothy Ang, Professor, Timothy.Ang@health.nsw.gov.au
Craig Anderson, Professor
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 2170
Christopher Blair, Dr, christopher.blair@health.nsw.gov.au
Christopher Blair, Dr
- Recruiting
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Chris Levi, Professor, Christopher.Levi@health.nsw.gov.au
Chris Levi, Professor
- Recruiting
Royal Melbourne Hospital
Parkville, Victoria, 3050
Bruce Campbell, Professor, bruce.campbell@mh.org.au
Bruce Campbell, Professor
- Recruiting
Prince of Wales Hospital
Randwick, New South Wales, 2031
Ken Butcher, Professor, ken.butcher@unsw.edu.au
Ken Butcher, Professor
About this study
STARS is a prospective, multicentre, open-label, dose escalation, Phase IIa study to assess the safety and tolerability of TBO-309, an adjuvant antiplatelet therapy, in patients with AIS.
Acute ischaemic stroke (AIS) is caused by a severe blockage of an artery leading to immediate reduced blood flow to part of the brain. Standard therapies target the blocked artery by either dissolving the blockage or removing the blockage. However, even after successful treatment, re-blockage of arteries can occur. The use of an antiplatelet therapy, TBO-309, in addition to standard therapies offers the possibility of improved restoration of blood flow and reduced rates of artery re-blockage.
Read the detailed description
Stroke is a leading cause of disability worldwide, with most strokes in Australia being Acute ischaemic stroke (AIS). AIS is caused by a severe blockage of an artery leading to immediate reduced blood flow to part of the brain. Timely restoration of blood flow is critical to preserve brain function. Standard therapies target the blocked artery by either dissolving the blockage (intravenous thrombolysis (IVT)) or removing the blockage (endovascular thrombectomy (EVT)). However, even after successful treatment, re-blockage of arteries can occur. The use of an antiplatelet therapy in addition to IVT/EVT offers the possibility of improved restoration of blood flow and reduced rates of artery re-blockage.
STARS is a prospective, multicentre, open-label, dose escalation, Phase IIa study to assess the safety and tolerability of TBO-309, an adjuvant antiplatelet therapy, in patients with AIS. The study will test the hypothesis that AIS patients who are treated with TBO-309 in conjunction with standard therapy (IVT alone or IVT + EVT) will not experience higher rates of ICH compared to the expected rates of ICH in patients treated with only standard therapy (IVT alone or IVT + EVT).
TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation, thereby specifically inhibiting thrombosis without interfering with normal haemostasis. In order to evaluate safety at lower doses, four dose levels in total will be administered using a serial dose-escalation design. Doses will be assigned based on a dose escalation methodology commencing with lower doses assigned early in the study. As safety criteria are satisfied (based on ICH rates) doses will be increased. The dosage strength of TBO-309 to be administered (30mg, 60mg, 120mg or 180mg) will be assigned by the study database.
Patients presenting to hospital with an AIS will be assessed according to the trial inclusion and exclusion criteria by the Principal Investigator, or nominated delegate, on admission to the Emergency Department. Consent will be sought from either the patient or their Person Responsible/Medical Treatment Decision Maker prior to enrolment into the study. Standard therapy, either IVT alone or IVT + EVT, will commence and the TBO-309 will be administered at the same time as standard therapy. Following administration of study drug and treatment with standard therapies, patients will receive usual supportive care either in the Intensive Care Unit or in the hospital ward. Any significant neurological deterioration will require an emergency non-contrast CT head to assess for the presence of ICH. All patients will receive a 24-36 hour MRI or a multimodal CT to assess asymptomatic bleeding, recanalisation and infarct volume.
During the patients hospital stay clinical outcome data will be collected during the study period to document response to treatment and to monitor safety. Study patients will be followed-up for 90 days post-enrolment, or to death, whichever is the earlier.
- Conditions
- Acute Ischemic Stroke
- Being tested
- TBO-309
- Keywords
- Antiplatelet therapy, Stroke, Blood clot, Intravenous thrombolysis (IVT), Endovascular Thrombectomy (EVT), TBO-309
- Medical subject headings
- Ischemic Stroke, Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBO-309Drug
TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation, thereby specifically inhibiting thrombosis without interfering with normal haemostasis.
| Study group | Role | What they receive |
|---|---|---|
| TBO-309 30mg (25% of target dose) | Experimental | Following randomisation, 30mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical.
The allocated dose of TBO-309 will be given intravenously as follows:
* 20% of the dose will be administered as a bolus over approximately one minute; then
* the remainder of the dose (80%) will be administered over 3 hours as an infusion
Only one dose will be administered to the patient. Receives: Drug: TBO-309 |
| TBO-309 60mg (50% of target dose) | Experimental | Following randomisation, 60mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical.
The allocated dose of TBO-309 will be given intravenously as follows:
* 20% of the dose will be administered as a bolus over approximately one minute; then
* the remainder of the dose (80%) will be administered over 3 hours as an infusion
Only one dose will be administered to the patient. Receives: Drug: TBO-309 |
| TBO-309 120mg (100% of target dose) | Experimental | Following randomisation, 120mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical.
The allocated dose of TBO-309 will be given intravenously as follows:
* 20% of the dose will be administered as a bolus over approximately one minute; then
* the remainder of the dose (80%) will be administered over 3 hours as an infusion
Only one dose will be administered to the patient. Receives: Drug: TBO-309 |
| TBO-309 180mg (150% of target dose) | Experimental | Following randomisation, 180mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical.
The allocated dose of TBO-309 will be given intravenously as follows:
* 20% of the dose will be administered as a bolus over approximately one minute; then
* the remainder of the dose (80%) will be administered over 3 hours as an infusion
Only one dose will be administered to the patient. Receives: Drug: TBO-309 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with ICH within 24-36 hours of study drug (TBO-309) commencement.
Proportion of patients with ICH within 24-36 hours of study drug (TBO-309) commencement. ICH is defined as parenchymal haemorrhage (PH) type II based on The Heidelberg Bleeding Classification or any intracranial haemorrhage leading to clinical deterioration i.e. an increase in NIHSS of 4 points or more, on post-intervention brain MRI with MRA or multimodal CT scan (see appendix 2 and 3). This definition allows the inclusion of any clinically and radiologically significant haemorrhage with the rate of expected ICH in this patient population estimated to be up to 8%
Measured: Within 24-36 hours of initiation of study drug
Secondary outcomes (4)
All bleeding
All bleeding within 72 hours of study drug (TBO-309) administration according to a modified WHO scale
Measured: Within 72 hours of study drug administration
All ICH
All ICH demonstrated on 24-36 hours imaging (recommended in patients who did not have the 2-6 hours imaging)
Measured: 24-36 hours
All intracerebral hemorrhage (ICH)
All ICH as demonstrated on CT/MRI up to 90 days
Measured: Up to 90 days post study drug administration
All bleeding
All bleeding reported up to 90 days according to a modified WHO scale
Measured: Up to 90 days post study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start27 Sep 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Continual Reassessment Method
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Florey Institute of Neuroscience and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Neuroscience Trials Australia
- Responsible party
- Sponsor
- Investigators
- Candice Delcourt, Dr, Study chair, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363397
- Sponsor's protocol ID
- CCD78277
- Other IDs
- U1111-1270-5195
- Acronym
- STARS
- Status last verified
- Nov 2025
- First submitted
- 2 May 2022
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
- ClinicalTrials.gov ID
- NCT05363397
- Acronym / sponsor ID
- STARS / CCD78277
- Conditions
- Acute Ischemic Stroke
- Keywords
- Antiplatelet therapy, Stroke, Blood clot, Intravenous thrombolysis (IVT), Endovascular Thrombectomy (EVT), TBO-309
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Florey Institute of Neuroscience and Mental HealthUniversity, hospital or other
- Collaborators
- Neuroscience Trials Australia
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 5 May 2022 (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.
STARS is a prospective, multicentre, open-label, dose escalation, Phase IIa study to assess the safety and tolerability of TBO-309, an adjuvant antiplatelet therapy, in patients with AIS.
Acute ischaemic stroke (AIS) is caused by a severe blockage of an artery leading to immediate reduced blood flow to part of the brain. Standard therapies target the blocked artery by either dissolving the blockage or removing the blockage. However, even after successful treatment, re-blockage of arteries can occur. The use of an antiplatelet therapy, TBO-309, in addition to standard therapies offers the possibility of improved restoration of blood flow and reduced rates of artery re-blockage.
Detailed description
Stroke is a leading cause of disability worldwide, with most strokes in Australia being Acute ischaemic stroke (AIS). AIS is caused by a severe blockage of an artery leading to immediate reduced blood flow to part of the brain. Timely restoration of blood flow is critical to preserve brain function. Standard therapies target the blocked artery by either dissolving the blockage (intravenous thrombolysis (IVT)) or removing the blockage (endovascular thrombectomy (EVT)). However, even after successful treatment, re-blockage of arteries can occur. The use of an antiplatelet therapy in addition to IVT/EVT offers the possibility of improved restoration of blood flow and reduced rates of artery re-blockage.
STARS is a prospective, multicentre, open-label, dose escalation, Phase IIa study to assess the safety and tolerability of TBO-309, an adjuvant antiplatelet therapy, in patients with AIS. The study will test the hypothesis that AIS patients who are treated with TBO-309 in conjunction with standard therapy (IVT alone or IVT + EVT) will not experience higher rates of ICH compared to the expected rates of ICH in patients treated with only standard therapy (IVT alone or IVT + EVT).
TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation, thereby specifically inhibiting thrombosis without interfering with normal haemostasis. In order to evaluate safety at lower doses, four dose levels in total will be administered using a serial dose-escalation design. Doses will be assigned based on a dose escalation methodology commencing with lower doses assigned early in the study. As safety criteria are satisfied (based on ICH rates) doses will be increased. The dosage strength of TBO-309 to be administered (30mg, 60mg, 120mg or 180mg) will be assigned by the study database.
Patients presenting to hospital with an AIS will be assessed according to the trial inclusion and exclusion criteria by the Principal Investigator, or nominated delegate, on admission to the Emergency Department. Consent will be sought from either the patient or their Person Responsible/Medical Treatment Decision Maker prior to enrolment into the study. Standard therapy, either IVT alone or IVT + EVT, will commence and the TBO-309 will be administered at the same time as standard therapy. Following administration of study drug and treatment with standard therapies, patients will receive usual supportive care either in the Intensive Care Unit or in the hospital ward. Any significant neurological deterioration will require an emergency non-contrast CT head to assess for the presence of ICH. All patients will receive a 24-36 hour MRI or a multimodal CT to assess asymptomatic bleeding, recanalisation and infarct volume.
During the patients hospital stay clinical outcome data will be collected during the study period to document response to treatment and to monitor safety. Study patients will be followed-up for 90 days post-enrolment, or to death, whichever is the earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Continual Reassessment Method
| Arm | Type | Receives |
|---|---|---|
| TBO-309 30mg (25% of target dose) | Experimental | Drug: TBO-309Following randomisation, 30mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical. The allocated dose of TBO-309 will be given intravenously as follows: * 20% of the dose will be administered as a bolus over approximately one minute; then * the remainder of the dose (80%) will be administered over 3 hours as an infusion Only one dose will be administered to the patient. |
| TBO-309 60mg (50% of target dose) | Experimental | Drug: TBO-309Following randomisation, 60mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical. The allocated dose of TBO-309 will be given intravenously as follows: * 20% of the dose will be administered as a bolus over approximately one minute; then * the remainder of the dose (80%) will be administered over 3 hours as an infusion Only one dose will be administered to the patient. |
| TBO-309 120mg (100% of target dose) | Experimental | Drug: TBO-309Following randomisation, 120mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical. The allocated dose of TBO-309 will be given intravenously as follows: * 20% of the dose will be administered as a bolus over approximately one minute; then * the remainder of the dose (80%) will be administered over 3 hours as an infusion Only one dose will be administered to the patient. |
| TBO-309 180mg (150% of target dose) | Experimental | Drug: TBO-309Following randomisation, 180mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical. The allocated dose of TBO-309 will be given intravenously as follows: * 20% of the dose will be administered as a bolus over approximately one minute; then * the remainder of the dose (80%) will be administered over 3 hours as an infusion Only one dose will be administered to the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient aged 18 years or more
- Patient has an acute ischaemic stroke
- Patient will be treated with either:
- alone/OR WITH
- OR
Key exclusion criteria (21 listed)
- Patient is considered unlikely to benefit from study intervention defined by one of the following:
- High likelihood of undergoing stent insertion and requiring additional antithrombotic(s)
- Uncontrolled hypertension (SBP >180 or DBP >110, refractory to medical therapy)
- ICH within the last 90 days
- Myocardial infarction or stroke within the last 30 days
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 |
|---|---|---|
| TBO-309TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation, thereby specifically inhibiting thrombosis without interfering with normal haemostasis. | Drug | TBO-309 120mg (100% of target dose), TBO-309 180mg (150% of target dose), TBO-309 30mg (25% of target dose), TBO-309 60mg (50% of target dose) |
Primary outcome
Proportion of patients with ICH within 24-36 hours of study drug (TBO-309) commencement.
Time frame: Within 24-36 hours of initiation of study drug
Proportion of patients with ICH within 24-36 hours of study drug (TBO-309) commencement. ICH is defined as parenchymal haemorrhage (PH) type II based on The Heidelberg Bleeding Classification or any intracranial haemorrhage leading to clinical deterioration i.e. an increase in NIHSS of 4 points or more, on post-intervention brain MRI with MRA or multimodal CT scan (see appendix 2 and 3). This definition allows the inclusion of any clinically and radiologically significant haemorrhage with the rate of expected ICH in this patient population estimated to be up to 8%
4 secondary outcomes
All bleeding
Time frame: Within 72 hours of study drug administration
All ICH
Time frame: 24-36 hours
All intracerebral hemorrhage (ICH)
Time frame: Up to 90 days post study drug administration
All bleeding
Time frame: Up to 90 days post study drug administration
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 1 Dec 2025.
- 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.
Candice Delcourt, Dr study chair
The George Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TBO-309 in people with Acute Ischemic Stroke, run by The Florey Institute of Neuroscience and Mental Health at 7 sites in Australia.
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 11 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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 Candice Delcourt, Dr (+61 2 8052 4601, cdelcourt@georgeinstitute.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with ICH within 24-36 hours of study drug (TBO-309) commencement. (time frame: Within 24-36 hours of initiation of study drug). 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 1 Dec 2025.