Ischemic StrokePhase 2Co-STARSNCT06813651
Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion
A Phase 2 study testing TBO-309: 60 mg, TBO-309: 120 mg and TBO-309: 30 mg in people with Ischemic Stroke and Tandem Occlusion, run by ThromBio Pty. Ltd. at 2 sites in Australia.
Trial summary
Co-STAR is a multicenter, prospective, open-label, Bayesian Optimal Phase 2 (BOP2) trial that aims to assess the safety and efficacy of adjunctive intravenous TBO-309 in Acute Ischaemic Stroke (AIS) patients with tandem occlusion receiving intra-cranial endovascular thrombectomy (EVT) and acute extracranial carotid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Tandem Occlusion
- What is being tested?
- TBO-309: 60 mg, TBO-309: 120 mg and TBO-309: 30 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesAustralia
- Study dates
- 4 Oct 2025to 31 Dec 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 AIS due to tandem occlusion, including large vessel occlusion (LVO) within the intra-cranial anterior circulation and presumed atherosclerotic occlusion of the cervical internal carotid artery origin
- CT perfusion indicates 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 (NIHSS >4)
- 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 middle cerebral artery (MCA) territory
- Uncontrolled hypertension (SBP >180 or DBP >110, refractory to medical therapy)
Show all 17Show fewer
- Intracranial haemorrhage 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
- Known treatment with anticoagulants
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ferdinand Miteff - Interventional Neurologist, RACP, CCINR contact
Australia2 sites, 2 recruiting
- Recruiting
John Hunter Hospital
Newcastle, New South Wales, 2305
Ferdinand Miteff, ferdi.miteff@health.nsw.gov.au
Ferdinand Miteff
- Not yet recruiting
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Alice Ma, MBBS, +61299267111, Alice.Ma@health.nsw.gov.au
Alice Ma, MBBS
About this study
Co-STAR is a multicenter, prospective, open-label, Bayesian Optimal Phase 2 (BOP2) trial that aims to assess the safety and efficacy of adjunctive intravenous TBO-309 in Acute Ischaemic Stroke (AIS) patients with tandem occlusion receiving intra-cranial endovascular thrombectomy (EVT) and acute extracranial carotid artery stenting.
Co-STARS study will test the hypothesis that patients with tandem occlusion treated with EVT and acute stenting in conjunction with TBO-309 will:
Read more
- have persistent stent patency without requiring rescue therapy with GPIIb/IIIa inhibitors and
- not experience high rates of symptomatic intra-cranial haemorrhage (sICH).
Patients with tandem occlusion undergoing EVT and acute stenting will receive intravenous TBO-309 bolus and infusion. TBO-309 is a potent, selective and ATP competitive PI3K[beta] inhibitor which reduces platelet activation adhesion/aggregation particularly under conditions of disturbed blood flow and promotes platelet disaggregation. By targeting PI3K[beta], TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal hemostasis.
Read the detailed description
Stroke due to large vessel occlusion (LVO) typically causes large infarcts and results in severe disability and a high case fatality rate. Treating LVO by thrombectomy poses technical challenges, especially when the lesion involves not only the extracranial (cervical) part of the internal carotid artery but also its concomitant intracranial distal segment or the ipsilateral middle cerebral artery (tandem occlusion). For patients with tandem occlusion, stenting of the internal carotid is considered acceptable, but it requires the use of antiplatelet therapy to avoid stent thrombosis, often necessitating rescue therapy with GPIIb/IIIa inhibitors. This can lead to an increased risk of hemorrhage especially when potent antiplatelet agents such as GPIIb/IIIa inhibitors are used.
The novel investigational agent TBO-309 is a potent, selective and ATP competitive PI3K[beta] inhibitor which reduces platelet activation adhesion/aggregation particularly under conditions of disturbed blood flow and promotes platelet disaggregation. By targeting PI3K[beta], TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal hemostasis. This study aims to assess the safety and efficacy of adjunctive TBO-309 in acute ischaemic stroke with tandem occlusion eligible to undergo intra-cranial EVT and acute extracranial carotid artery stenting.
The primary endpoint of this trial is a composite outcome of efficacy and safety, defined by:
- Avoidance of intra-procedural GPIIb/IIIa inhibitor rescue therapy due to stent thrombosis, combined with persistent stent patency seen on angiographic imaging at 24-36 hours, and
- no sICH.
This trial will use Bayesian Optimal Phase 2 (BOP2) trial design, and two intervention doses will be tested sequentially for TBO-309. TBO-309 at the dose of 60 mg will be tested first. Then either a higher dose of 120 mg or a lower dose of 30 mg will be tested based on the results of the 60 mg dose.
- Conditions
- Ischemic Stroke, Tandem Occlusion
- Being tested
- TBO-309: 60 mg, TBO-309: 120 mg, TBO-309: 30 mg
- Keywords
- Ischaemic stroke, Stenting, Endovascular thrombectomy, tandem occlusion
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBO-309: 60 mgDrug
TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation. By targeting PI3Kβ, TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal haemostasis.
TBO-309: 120 mgDrug
TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation. By targeting PI3Kβ, TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal haemostasis.
TBO-309: 30 mgDrug
TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation. By targeting PI3Kβ, TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal haemostasis.
| Study group | Role | What they receive |
|---|---|---|
| TBO-309 - 60 mg | Experimental | An intravenous (IV) bolus of TBO-309 will be administered before the acute stent procedure. The allocated dose of TBO-309 will be given IV 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. Receives: Drug: TBO-309: 60 mg |
| TBO-309 - 120 mg | Experimental | An intravenous (IV) bolus of TBO-309 will be administered before the acute stent procedure. The allocated dose of TBO-309 will be given IV 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. Receives: Drug: TBO-309: 120 mg |
| TBO-309 - 30 mg | Experimental | An intravenous (IV) bolus of TBO-309 will be administered before the acute stent procedure. The allocated dose of TBO-309 will be given IV 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. Receives: Drug: TBO-309: 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving a composite outcome of efficacy and safety
The primary endpoint is a composite outcome of efficacy and safety, defined by the proportion of patients who 1) avoid intra-procedural GPIIb/IIIa inhibitor rescue therapy due to stent thrombosis, combined with persistent stent patency seen on angiographic imaging at 24-36 hours, and 2) have no sICH. sICH is defined as parenchymal haemorrhage type 2 (PH2) on imaging.
Measured: 24-36 hours
Secondary outcomes (7)
Proportion of patients achieving reperfusion.
The proportion of patients achieving reperfusion, where reperfusion is defined by the expanded Thrombolysis in Cerebral Infarction scale (eTICI) 2b50 or better (i.e. 50% to 100%)
Measured: 24 hours
Infarct volume 24-36 hours post study drug commencement
Measured: 24-36 hours
Proportion of all patients with any ICH within 24-36 hours post study drug commencement
All ICH as demonstrated on brain imaging at 24-36 hours, where ICH will be classified according to The Heidelberg Bleeding Classification.
Measured: 24-36 hours
Proportion of patients experiencing any bleeding within 24-36 hours of study drug commencement.
The proportion of patients experiencing any bleeding within 24-36 hours of study drug commencement. Bleeding will be determined using a modified WHO scale with grades 1 and 2 classified as minor bleeding, and grades 3 and 4 as major bleeding.
Measured: 24-36 hours
National Institutes of Health Stroke Scale (NIHSS) at 24 hours, and 7 days/at hospital Discharge
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurological examination stroke scale. Scores range from 0 to 42, with higher scores indicating greater severity.
Measured: 24 hours and 7 days
Modified Rankin Scale (mRS) score at discharge and 90 days
The Modified Rankin Scale (mRS) is a scale from 0 to 6, with higher scores indicating greater disability (5), and death (6).
Measured: 90 days
Proportion of patients with all-cause mortality at 90 days.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start4 Oct 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for 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
- Multicenter, prospective, open-label, Bayesian Optimal Phase 2 (BOP2) trial. Two intervention doses will be tested sequentially for TBO-309, with 60mg tested first. Then either a higher (120mg) or lower (30mg) dose will be tested, based on results of the 60 mg dose. The maximum number of subjects is estimated to be 78 in this two-dose BOP2 design study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ThromBio Pty. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ferdinand Miteff - Interventional Neurologist, RACP, CCINR, Principal investigator, John Hunter Hospital, Newcastle, NSW Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813651
- Sponsor's protocol ID
- Co-STARS
- Other IDs
- Application No. 00039
- Acronym
- Co-STARS
- Status last verified
- Nov 2025
- First submitted
- 21 Jan 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Saver JL, Chaisinanunkul N, Campbell BCV, Grotta JC, Hill MD, Khatri P, Landen J, Lansberg MG, Venkatasubramanian C, Albers GW; XIth Stroke Treatment Academic Industry Roundtable. Standardized Nomenclature for Modified Rankin Scale Global Disability Outcomes: Consensus Recommendations From Stroke Therapy Academic Industry Roundtable XI. Stroke. 2021 Aug;52(9):3054-3062. doi: 10.1161/STROKEAHA.121.034480. Epub 2021 Jul 29.
PubMed 34320814Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer. 1981 Jan 1;47(1):207-14. doi: 10.1002/1097-0142(19810101)47:13.0.co;2-6.
PubMed 7459811Heddle NM, Cook RJ, Tinmouth A, Kouroukis CT, Hervig T, Klapper E, Brandwein JM, Szczepiorkowski ZM, AuBuchon JP, Barty RL, Lee KA; SToP Study Investigators of the BEST Collaborative. A randomized controlled trial comparing standard- and low-dose strategies for transfusion of platelets (SToP) to patients with thrombocytopenia. Blood. 2009 Feb 12;113(7):1564-73. doi: 10.1182/blood-2008-09-178236. Epub 2008 Dec 24.
PubMed 19109560von Kummer R, Broderick JP, Campbell BC, Demchuk A, Goyal M, Hill MD, Treurniet KM, Majoie CB, Marquering HA, Mazya MV, San Roman L, Saver JL, Strbian D, Whiteley W, Hacke W. The Heidelberg Bleeding Classification: Classification of Bleeding Events After Ischemic Stroke and Reperfusion Therapy. Stroke. 2015 Oct;46(10):2981-6. doi: 10.1161/STROKEAHA.115.010049. Epub 2015 Sep 1. No abstract available.
PubMed 26330447Wahlgren N, Ahmed N, Davalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V, Lees KR, Roine RO, Soinne L, Toni D, Vanhooren G; SITS-MOST investigators. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet. 2007 Jan 27;369(9558):275-82. doi: 10.1016/S0140-6736(07)60149-4.
PubMed 17258667Jackson SP, Schoenwaelder SM. Antithrombotic phosphoinositide 3-kinase beta inhibitors in humans: a 'shear' delight! J Thromb Haemost. 2012 Oct;10(10):2123-6. doi: 10.1111/j.1538-7836.2012.04912.x. No abstract available.
PubMed 22943292Nylander S, Wagberg F, Andersson M, Skarby T, Gustafsson D. Exploration of efficacy and bleeding with combined phosphoinositide 3-kinase beta inhibition and aspirin in man. J Thromb Haemost. 2015 Aug;13(8):1494-502. doi: 10.1111/jth.13027. Epub 2015 Jul 23.
PubMed 26096765Nylander S, Kull B, Bjorkman JA, Ulvinge JC, Oakes N, Emanuelsson BM, Andersson M, Skarby T, Inghardt T, Fjellstrom O, Gustafsson D. Human target validation of phosphoinositide 3-kinase (PI3K)beta: effects on platelets and insulin sensitivity, using AZD6482 a novel PI3Kbeta inhibitor. J Thromb Haemost. 2012 Oct;10(10):2127-36. doi: 10.1111/j.1538-7836.2012.04898.x.
PubMed 22906130Jackson SP, Schoenwaelder SM, Goncalves I, Nesbitt WS, Yap CL, Wright CE, Kenche V, Anderson KE, Dopheide SM, Yuan Y, Sturgeon SA, Prabaharan H, Thompson PE, Smith GD, Shepherd PR, Daniele N, Kulkarni S, Abbott B, Saylik D, Jones C, Lu L, Giuliano S, Hughan SC, Angus JA, Robertson AD, Salem HH. PI 3-kinase p110beta: a new target for antithrombotic therapy. Nat Med. 2005 May;11(5):507-14. doi: 10.1038/nm1232. Epub 2005 Apr 17.
PubMed 15834429
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion
- ClinicalTrials.gov ID
- NCT06813651
- Acronym / sponsor ID
- Co-STARS / Co-STARS
- Conditions
- Ischemic Stroke, Tandem Occlusion
- Keywords
- Ischaemic stroke, Stenting, Endovascular thrombectomy, tandem occlusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- ThromBio Pty. Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Feb 2025 (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.
Co-STAR is a multicenter, prospective, open-label, Bayesian Optimal Phase 2 (BOP2) trial that aims to assess the safety and efficacy of adjunctive intravenous TBO-309 in Acute Ischaemic Stroke (AIS) patients with tandem occlusion receiving intra-cranial endovascular thrombectomy (EVT) and acute extracranial carotid artery stenting.
Co-STARS study will test the hypothesis that patients with tandem occlusion treated with EVT and acute stenting in conjunction with TBO-309 will:
- have persistent stent patency without requiring rescue therapy with GPIIb/IIIa inhibitors and
- not experience high rates of symptomatic intra-cranial haemorrhage (sICH).
Patients with tandem occlusion undergoing EVT and acute stenting will receive intravenous TBO-309 bolus and infusion. TBO-309 is a potent, selective and ATP competitive PI3K[beta] inhibitor which reduces platelet activation adhesion/aggregation particularly under conditions of disturbed blood flow and promotes platelet disaggregation. By targeting PI3K[beta], TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal hemostasis.
Detailed description
Stroke due to large vessel occlusion (LVO) typically causes large infarcts and results in severe disability and a high case fatality rate. Treating LVO by thrombectomy poses technical challenges, especially when the lesion involves not only the extracranial (cervical) part of the internal carotid artery but also its concomitant intracranial distal segment or the ipsilateral middle cerebral artery (tandem occlusion). For patients with tandem occlusion, stenting of the internal carotid is considered acceptable, but it requires the use of antiplatelet therapy to avoid stent thrombosis, often necessitating rescue therapy with GPIIb/IIIa inhibitors. This can lead to an increased risk of hemorrhage especially when potent antiplatelet agents such as GPIIb/IIIa inhibitors are used.
The novel investigational agent TBO-309 is a potent, selective and ATP competitive PI3K[beta] inhibitor which reduces platelet activation adhesion/aggregation particularly under conditions of disturbed blood flow and promotes platelet disaggregation. By targeting PI3K[beta], TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal hemostasis. This study aims to assess the safety and efficacy of adjunctive TBO-309 in acute ischaemic stroke with tandem occlusion eligible to undergo intra-cranial EVT and acute extracranial carotid artery stenting.
The primary endpoint of this trial is a composite outcome of efficacy and safety, defined by:
- Avoidance of intra-procedural GPIIb/IIIa inhibitor rescue therapy due to stent thrombosis, combined with persistent stent patency seen on angiographic imaging at 24-36 hours, and
- no sICH.
This trial will use Bayesian Optimal Phase 2 (BOP2) trial design, and two intervention doses will be tested sequentially for TBO-309. TBO-309 at the dose of 60 mg will be tested first. Then either a higher dose of 120 mg or a lower dose of 30 mg will be tested based on the results of the 60 mg dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Multicenter, prospective, open-label, Bayesian Optimal Phase 2 (BOP2) trial. Two intervention doses will be tested sequentially for TBO-309, with 60mg tested first. Then either a higher (120mg) or lower (30mg) dose will be tested, based on results of the 60 mg dose. The maximum number of subjects is estimated to be 78 in this two-dose BOP2 design study.
| Arm | Type | Receives |
|---|---|---|
| TBO-309 - 60 mg | Experimental | Drug: TBO-309: 60 mgAn intravenous (IV) bolus of TBO-309 will be administered before the acute stent procedure. The allocated dose of TBO-309 will be given IV 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. |
| TBO-309 - 120 mg | Experimental | Drug: TBO-309: 120 mgAn intravenous (IV) bolus of TBO-309 will be administered before the acute stent procedure. The allocated dose of TBO-309 will be given IV 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. |
| TBO-309 - 30 mg | Experimental | Drug: TBO-309: 30 mgAn intravenous (IV) bolus of TBO-309 will be administered before the acute stent procedure. The allocated dose of TBO-309 will be given IV 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged 18 years or more
- Patient has an AIS due to tandem occlusion, including large vessel occlusion (LVO) within the intra-cranial anterior circulation and presumed atherosclerotic occlusion of the cervical internal carotid artery origin
- CT perfusion indicates 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 (NIHSS >4)
- Patient has an estimated pre-stroke mRS of less than 4
Key exclusion criteria (17 listed)
- Patient is considered unlikely to benefit from study intervention defined by one of the following:
- Uncontrolled hypertension (SBP >180 or DBP >110, refractory to medical therapy)
- Intracranial haemorrhage 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
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-309: 60 mgTBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation. By targeting PI3Kβ, TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal haemostasis. | Drug | TBO-309 - 60 mg |
| TBO-309: 120 mgTBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation. By targeting PI3Kβ, TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal haemostasis. | Drug | TBO-309 - 120 mg |
| TBO-309: 30 mgTBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation. By targeting PI3Kβ, TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal haemostasis. | Drug | TBO-309 - 30 mg |
Primary outcome
Proportion of patients achieving a composite outcome of efficacy and safety
Time frame: 24-36 hours
The primary endpoint is a composite outcome of efficacy and safety, defined by the proportion of patients who 1) avoid intra-procedural GPIIb/IIIa inhibitor rescue therapy due to stent thrombosis, combined with persistent stent patency seen on angiographic imaging at 24-36 hours, and 2) have no sICH. sICH is defined as parenchymal haemorrhage type 2 (PH2) on imaging.
7 secondary outcomes
Proportion of patients achieving reperfusion.
Time frame: 24 hours
Infarct volume 24-36 hours post study drug commencement
Time frame: 24-36 hours
Proportion of all patients with any ICH within 24-36 hours post study drug commencement
Time frame: 24-36 hours
Proportion of patients experiencing any bleeding within 24-36 hours of study drug commencement.
Time frame: 24-36 hours
National Institutes of Health Stroke Scale (NIHSS) at 24 hours, and 7 days/at hospital Discharge
Time frame: 24 hours and 7 days
Modified Rankin Scale (mRS) score at discharge and 90 days
Time frame: 90 days
Proportion of patients with all-cause mortality at 90 days.
Time frame: 90 days
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 25 Nov 2025.
- Background: PubMed 34320814Saver JL, Chaisinanunkul N, Campbell BCV, Grotta JC, Hill MD, Khatri P, Landen J, Lansberg MG, Venkatasubramanian C, Albers GW; XIth Stroke Treatment Academic Industry Roundtable. Standardized Nomenclature for Modified Rankin Scale Global Disability Outcomes: Consensus Recommendations From Stroke Therapy Academic Industry Roundtable XI. Stroke. 2021 Aug;52(9):3054-3062. doi: 10.1161/STROKEAHA.121.034480. Epub 2021 Jul 29.
- Background: PubMed 7459811Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer. 1981 Jan 1;47(1):207-14. doi: 10.1002/1097-0142(19810101)47:13.0.co;2-6.
- Background: PubMed 19109560Heddle NM, Cook RJ, Tinmouth A, Kouroukis CT, Hervig T, Klapper E, Brandwein JM, Szczepiorkowski ZM, AuBuchon JP, Barty RL, Lee KA; SToP Study Investigators of the BEST Collaborative. A randomized controlled trial comparing standard- and low-dose strategies for transfusion of platelets (SToP) to patients with thrombocytopenia. Blood. 2009 Feb 12;113(7):1564-73. doi: 10.1182/blood-2008-09-178236. Epub 2008 Dec 24.
- Background: PubMed 26330447von Kummer R, Broderick JP, Campbell BC, Demchuk A, Goyal M, Hill MD, Treurniet KM, Majoie CB, Marquering HA, Mazya MV, San Roman L, Saver JL, Strbian D, Whiteley W, Hacke W. The Heidelberg Bleeding Classification: Classification of Bleeding Events After Ischemic Stroke and Reperfusion Therapy. Stroke. 2015 Oct;46(10):2981-6. doi: 10.1161/STROKEAHA.115.010049. Epub 2015 Sep 1. No abstract available.
- Background: PubMed 17258667Wahlgren N, Ahmed N, Davalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V, Lees KR, Roine RO, Soinne L, Toni D, Vanhooren G; SITS-MOST investigators. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet. 2007 Jan 27;369(9558):275-82. doi: 10.1016/S0140-6736(07)60149-4.
- Background: PubMed 22943292Jackson SP, Schoenwaelder SM. Antithrombotic phosphoinositide 3-kinase beta inhibitors in humans: a 'shear' delight! J Thromb Haemost. 2012 Oct;10(10):2123-6. doi: 10.1111/j.1538-7836.2012.04912.x. No abstract available.
- Background: PubMed 26096765Nylander S, Wagberg F, Andersson M, Skarby T, Gustafsson D. Exploration of efficacy and bleeding with combined phosphoinositide 3-kinase beta inhibition and aspirin in man. J Thromb Haemost. 2015 Aug;13(8):1494-502. doi: 10.1111/jth.13027. Epub 2015 Jul 23.
- Background: PubMed 22906130Nylander S, Kull B, Bjorkman JA, Ulvinge JC, Oakes N, Emanuelsson BM, Andersson M, Skarby T, Inghardt T, Fjellstrom O, Gustafsson D. Human target validation of phosphoinositide 3-kinase (PI3K)beta: effects on platelets and insulin sensitivity, using AZD6482 a novel PI3Kbeta inhibitor. J Thromb Haemost. 2012 Oct;10(10):2127-36. doi: 10.1111/j.1538-7836.2012.04898.x.
- Background: PubMed 15834429Jackson SP, Schoenwaelder SM, Goncalves I, Nesbitt WS, Yap CL, Wright CE, Kenche V, Anderson KE, Dopheide SM, Yuan Y, Sturgeon SA, Prabaharan H, Thompson PE, Smith GD, Shepherd PR, Daniele N, Kulkarni S, Abbott B, Saylik D, Jones C, Lu L, Giuliano S, Hughan SC, Angus JA, Robertson AD, Salem HH. PI 3-kinase p110beta: a new target for antithrombotic therapy. Nat Med. 2005 May;11(5):507-14. doi: 10.1038/nm1232. Epub 2005 Apr 17.
- Individual participant dataSharing planned: Undecided
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Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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.
Ferdinand Miteff - Interventional Neurologist, RACP, CCINR contact
Ferdinand Miteff - Interventional Neurologist, RACP, CCINR principal investigator
John Hunter Hospital, Newcastle, NSW Australia
2 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: 60 mg, TBO-309: 120 mg and TBO-309: 30 mg in people with Ischemic Stroke and Tandem Occlusion, run by ThromBio Pty. Ltd. at 2 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 5 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Ferdinand Miteff - Interventional Neurologist, RACP, CCINR (612 4921 3490, ferdi.miteff@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving a composite outcome of efficacy and safety (time frame: 24-36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06813651, which also lists 9 linked publications.
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 25 Nov 2025.