IDH Wildtype GlioblastomaEarly Phase 1BRAid GBMNCT07908147
Biomarker-guided RAdiation-deferring Treatment in Younger GBM Patients - Pilot Study
A Early Phase 1 study testing Larotrectinib, Cadonilimab and Plixorafenib in people with IDH Wildtype Glioblastoma and Glioblastoma (GBM), run by Olivia Newton-John Cancer Research Institute at 1 site in Australia.
Trial summary
This study will investigate whether rapid molecular testing of recurrent glioblastoma (GBM) can identify tumour biomarkers that may help guide treatment selection in younger people with IDH-wildtype GBM. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- IDH Wildtype Glioblastoma, Glioblastoma (GBM)
- What is being tested?
- Larotrectinib, Cadonilimab and Plixorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2027to Mar 2028
- Phase
- Early Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patient who is aged 18-≤55 years of age
- Has MRI features consistent with a high-grade glioma
- Is planned for standard of care biopsy or surgery to investigate and/or treat this lesion
- ECOG 0-1
- Provides informed written consent
- Aged 18 to ≤55-years of age
Show all 24Show fewer
- Newly diagnosed patient with IDH-wildtype glioblastoma as per WHO 2021, or morphological features consistent with glioblastoma but pending confirmatory NGS or other profiling
- ECOG 0-1
- Consents to, and has sufficient tissue, for:
- IHC for BRAF V600E, pan-TRK and MMR proteins
- Further confirmatory NGS for NTRK fusions if pan-TRK IHC is positive
- Life expectancy of at least 12 weeks
- Newly diagnosed patients with IDH-wildtype glioblastoma as per WHO 2021
- Able to provide written informed consent
- Aged 18 to ≤55-years of age
- ECOG 0-1
- Adequate organ function as defined by
- Hepatic: total bilirubin ≤2.0 × upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤1.5 × ULN
- Renal: estimated glomerular filtration rate (GFR) ≥60 mL/min
- Bone marrow: platelets ≥100 × 109/L, absolute neutrophil count (ANC) ≥1.5 × 109/L, haemoglobin ≥9 g/dL
- If the patient is a male or female with reproductive potential, the patient is willing to use an approved contraceptive method (e.g., intrauterine device [IUD], birth control pills, or barrier device) during and for three months after discontinuation of study drug
- If the patient is a woman of childbearing potential, she has a negative serum pregnancy test within seven days prior to study enrollment
- Life expectancy of at least 12 weeks
- Patient is on stable or reducing dose of steroid within the first week of study enrolment, not exceeding a dose of dexamethasone 2 mg or equivalent
Who cannot join
- Prior radiation or systemic treatment for glioblastoma
- Multi-focal disease not likely to be encompassed within a standard radiotherapy field, infratentorial disease or leptomeningeal disease
- Evidence of significant acute intracranial or intra-tumoural haemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan.
- Serious intercurrent illness, as determined by the treating physician, that would compromise either patient safety or study outcomes.
- Key Eligibility Criteria (Post-Operative Screening)
- Diagnostic biopsy/craniotomy more than 2-weeks prior to study screening such that insufficient time for molecular profiling
Show all 24Show fewer
- Prior radiation or systemic treatment for glioblastoma
- Placement of Gliadel wafers or receipt of any other local investigational therapy at the time of surgery
- Multi-focal disease not encompassed within a standard radiotherapy field, infratentorial disease or leptomeningeal disease
- Evidence of significant acute intracranial or intra-tumoural haemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan
- Serious intercurrent illness, as determined by the treating physician, that would compromise either patient safety or study outcomes
- Key Eligibility Criteria (for patients being offered trial treatment)
- Prior radiation or systemic anti-cancer treatment for glioblastoma or any glioma, including a history of lower grade glioma
- Placement of Gliadel wafers or receipt of any other local investigational therapy at the time of surgery
- Multi-focal disease not encompassed within a standard radiotherapy field, infratentorial disease or leptomeningeal disease
- Evidence of significant acute intracranial or intra-tumoral haemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan as per clinician discretion. (Note: Patients with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are not excluded).
- Pregnant or breastfeeding at time of screening
- Any significant concomitant disorder, including active bacterial, fungal, or viral infection, incompatible with participation in the study
- History of another malignancy, except adequately treated non melanoma skin cancer or carcinoma in-situ of the cervix. Patients with prior malignancy are excluded unless they have been disease free for ≥ 2 years
- Known history of HIV, hepatitis B or hepatitis C
- Clinically significant gastrointestinal disorder that is expected to compromise absorption of oral medication, as determined by the treating physician for those receiving toral therapy
- Any serious intercurrent illness, as determined by the treating physician, that would compromise either patient safety or study outcomes
- Psychiatric illness or a social situation that would limit compliance with the study procedures requirements
- QTc interval > 470 milliseconds on screening ECG
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Austin Hospital
Heidelberg, Victoria, 3084
Hui Prof. Gan, +61 3 9496 9143, hui.gan@austin.org.au
About this study
Official title: Biomarker-guided RAdiation-deferring Treatment in Younger GBM Patients (BRAid GBM) Pilot Study
This study will investigate whether rapid molecular testing of recurrent glioblastoma (GBM) can identify tumour biomarkers that may help guide treatment selection in younger people with IDH-wildtype GBM. Participants will be people under 55 years of age whose diagnosis is consistent with glioblastoma and who have undergone recent surgery or previously participated in the initial phase of the BRAid GBM study.
Tumour tissue will undergo rapid molecular testing to identify biomarkers that may predict response to specific targeted treatments. Treatment decisions will be informed by the molecular characteristics of each participant's tumour and available evidence for treatments associated with the identified biomarkers.
Read more
The study will assess the feasibility and safety of implementing rapid molecular testing across multiple Australian hospitals and whether this approach can provide timely information to support personalised treatment decisions. The study will also explore whether biomarker-guided treatment may provide alternatives to, or reduce the use of, radiotherapy in younger people with glioblastoma, with the potential to reduce long-term treatment-related effects on cognition and quality of life.
Approximately 110 patients will be screened and 12 participants will be recruited from participating hospitals across Australia.
Read the detailed description
The BRAid GBM study is evaluating a novel treatment approach for younger people (under 55 years of age) with glioblastoma (GBM), an aggressive form of brain cancer. Standard treatment for GBM generally involves surgery followed by radiotherapy and chemotherapy. Although this approach can help control the disease, radiotherapy can cause long-term effects on brain function, including difficulties with memory, thinking and concentration, which may significantly affect quality of life, work and family life.
A small proportion of glioblastomas harbour specific molecular alterations that may make the tumour susceptible to targeted therapies. These include alterations involving the BRAF and NTRK genes and deficiency of the mismatch repair (MMR) system. Targeted therapies directed at these molecular abnormalities have demonstrated clinical benefit in other cancers and, in some cases, in patients with brain tumours. The BRAid GBM study will investigate whether rapid molecular testing of tumour tissue obtained at surgery can identify these alterations and enable treatment to be selected according to the molecular characteristics of an individual's tumour.
Patients whose tumours harbour an actionable biomarker may receive a matched targeted therapy: plixorafenib for BRAF-altered tumours, larotrectinib for NTRK fusion-positive tumours, or cadonilimab for MMR-deficient tumours. Patients whose tumours do not demonstrate an eligible biomarker will proceed with standard treatment with radiotherapy and chemotherapy. This approach is intended to determine whether rapid molecular profiling can identify patients who may be suitable for an alternative treatment strategy while maintaining timely access to standard care when targeted treatment is not indicated.
Participants will undergo regular clinical assessments and MRI scans to monitor tumour response and disease progression, together with quality-of-life and cognitive assessments to evaluate the effects of treatment on neurological and functional outcomes. Blood and tumour samples will also be collected for translational research to investigate the biological characteristics of glioblastoma and factors that may influence treatment response or resistance.
- Conditions
- IDH Wildtype Glioblastoma, Glioblastoma (GBM)
- Being tested
- Larotrectinib, Cadonilimab, Plixorafenib
- Keywords
- Glioblastoma, IDH wildtype Glioblastoma, BRAid GBM, Larotrectinib, Plixorafenib, Cadonilimab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LarotrectinibDrug
Larotrectinib is a first-in-class, highly selective, oral inhibitor of the tropomyosin receptor kinase (TRK) family of proteins (TRKA, TRKB and TRKC).
CadonilimabDrug
AK104 is bispecific IgG single chain Fv fragment (ScFv) monoclonal antibody that binds to human programmed cell death 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
PlixorafenibDrug
Plixorafenib is a next generation, orally available, small-molecule, selective inhibitor of Class 1 and 2 mutated BRAF.
| Study group | Role | What they receive |
|---|---|---|
| BRAF-altered | Experimental | Plixorafenib 900 mg orally once daily continuously Receives: Drug: Plixorafenib |
| NTRK fusion-positive | Experimental | Larotrectinib 100 mg orally twice daily continuously Receives: Drug: Larotrectinib |
| Mismatch repair deficient | Experimental | Cadonilimab 6 mg/kg intravenously on Days 1 and 15 Receives: Drug: Cadonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Rapid Molecular Profiling and Matched Targeted Therapy
To assess the feasibility of performing rapid molecular profiling before chemoradiation and initiating matched targeted therapy in patients with actionable molecular alterations.
Measured: From enrollment to initiation of chemoradiation (pre-treatment period).
Secondary outcomes (8)
Number and Percentage of Participants Experiencing Adverse Events by CTCAE Grade
Toxicity of treatment with plixorafenib, cadonilimab, or larotrectinib will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 6.0. The number and percentage of participants experiencing adverse events will be summarized by CTCAE severity grade and, where applicable, relationship to study treatment.
Measured: From Cycle 1 Day 1 (each cycle is 28 days) until 30 days after the end of study treatment.
Efficacy of Induction Targeted Therapy in Newly Diagnosed Glioblastoma
To assess the efficacy of induction treatment with plixorafenib, cadonilimab, or larotrectinib in patients with newly diagnosed glioblastoma and eligible molecular profiles, measured by progression-free survival (PFS) and time to next intervention (TTNI)
Measured: From Cycle 1 Day 1 (each cycle is 28 days) until the commencement of the next anti-cancer intervention or death from any cause, whichever occurs first.
Change in Quality of Life Scores as Assessed by the EORTC QLQ-C30 Questionarrie
The effect of upfront treatment with plixorafenib, cadonilimab, or larotrectinib on quality of life in patients with newly diagnosed glioblastoma with eligible molecular phenotypes will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores will be calculated according to the questionnaire scoring manual.
Measured: From Cycle 1 Day 1 (each cycle is 28 days) through the end of treatment (EOT), up to 12 months.
Change in Learning and Memory Scores as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R)
Neurocognitive function in patients with newly diagnosed glioblastoma and eligible molecular profiles will be assessed using the Hopkins Verbal Learning Test-Revised (HVLT-R), which evaluates verbal learning and memory.
Measured: At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis.
Change in Quality of Life Scores as Assessed by the EORTC QLQ-BN20 Questionarrie
The effect of upfront treatment with plixorafenib, cadonilimab, or larotrectinib on brain tumour-specific quality of life in patients with newly diagnosed glioblastoma with eligible molecular phenotypes will be assessed using the European Organisation for Research and Treatment of Cancer Brain Neoplasm Module (EORTC QLQ-BN20). Scores will be calculated according to the questionnaire scoring manual.
Measured: From Cycle 1 Day 1 (each cycle is 28 days) through the end of treatment (EOT), up to 12 months.
Change in Attention and Working Memory Scores as Assessed by the Wechsler Adult Intelligence Scale Digit Span Test
Attention and working memory will be assessed using the Digit Span subtest of the Wechsler Adult Intelligence Scale (WAIS). Changes in scores from baseline will be summarized over the assessment period.
Measured: At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis.
Change in Processing Speed as Assessed by Trail Making Test Part A
Processing speed will be assessed using Trail Making Test Part A. Changes in test performance from baseline will be summarized over the assessment period.
Measured: At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis.
Change in Executive Function as Assessed by Verbal Fluency and Trail Making Test Part B
Executive function will be assessed using verbal fluency testing and Trail Making Test Part B. Changes in test performance from baseline will be summarized over the assessment period.
Measured: At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startMar 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IDH Wildtype GlioblastomaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olivia Newton-John Cancer Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Fore Biotherapeutics, Akesobio Australia Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Hui Gan, MBBS, FRACP, Principal investigator, Olivia Newton-John Cancer Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908147
- Sponsor's protocol ID
- ONJ2026-002
- Acronym
- BRAid GBM
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing to occur at publication.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker-guided RAdiation-deferring Treatment in Younger GBM Patients (BRAid GBM) Pilot Study
- ClinicalTrials.gov ID
- NCT07908147
- Acronym / sponsor ID
- BRAid GBM / ONJ2026-002
- Conditions
- IDH Wildtype Glioblastoma, Glioblastoma (GBM)
- Keywords
- Glioblastoma, IDH wildtype Glioblastoma, BRAid GBM, Larotrectinib, Plixorafenib, Cadonilimab
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Olivia Newton-John Cancer Research InstituteUniversity, hospital or other
- Collaborators
- Fore Biotherapeutics, Akesobio Australia Pty Ltd
- Study start
- Mar 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 30 Oct 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.
This study will investigate whether rapid molecular testing of recurrent glioblastoma (GBM) can identify tumour biomarkers that may help guide treatment selection in younger people with IDH-wildtype GBM. Participants will be people under 55 years of age whose diagnosis is consistent with glioblastoma and who have undergone recent surgery or previously participated in the initial phase of the BRAid GBM study.
Tumour tissue will undergo rapid molecular testing to identify biomarkers that may predict response to specific targeted treatments. Treatment decisions will be informed by the molecular characteristics of each participant's tumour and available evidence for treatments associated with the identified biomarkers.
The study will assess the feasibility and safety of implementing rapid molecular testing across multiple Australian hospitals and whether this approach can provide timely information to support personalised treatment decisions. The study will also explore whether biomarker-guided treatment may provide alternatives to, or reduce the use of, radiotherapy in younger people with glioblastoma, with the potential to reduce long-term treatment-related effects on cognition and quality of life.
Approximately 110 patients will be screened and 12 participants will be recruited from participating hospitals across Australia.
Detailed description
The BRAid GBM study is evaluating a novel treatment approach for younger people (under 55 years of age) with glioblastoma (GBM), an aggressive form of brain cancer. Standard treatment for GBM generally involves surgery followed by radiotherapy and chemotherapy. Although this approach can help control the disease, radiotherapy can cause long-term effects on brain function, including difficulties with memory, thinking and concentration, which may significantly affect quality of life, work and family life.
A small proportion of glioblastomas harbour specific molecular alterations that may make the tumour susceptible to targeted therapies. These include alterations involving the BRAF and NTRK genes and deficiency of the mismatch repair (MMR) system. Targeted therapies directed at these molecular abnormalities have demonstrated clinical benefit in other cancers and, in some cases, in patients with brain tumours. The BRAid GBM study will investigate whether rapid molecular testing of tumour tissue obtained at surgery can identify these alterations and enable treatment to be selected according to the molecular characteristics of an individual's tumour.
Patients whose tumours harbour an actionable biomarker may receive a matched targeted therapy: plixorafenib for BRAF-altered tumours, larotrectinib for NTRK fusion-positive tumours, or cadonilimab for MMR-deficient tumours. Patients whose tumours do not demonstrate an eligible biomarker will proceed with standard treatment with radiotherapy and chemotherapy. This approach is intended to determine whether rapid molecular profiling can identify patients who may be suitable for an alternative treatment strategy while maintaining timely access to standard care when targeted treatment is not indicated.
Participants will undergo regular clinical assessments and MRI scans to monitor tumour response and disease progression, together with quality-of-life and cognitive assessments to evaluate the effects of treatment on neurological and functional outcomes. Blood and tumour samples will also be collected for translational research to investigate the biological characteristics of glioblastoma and factors that may influence treatment response or resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BRAF-altered | Experimental | Drug: PlixorafenibPlixorafenib 900 mg orally once daily continuously |
| NTRK fusion-positive | Experimental | Drug: LarotrectinibLarotrectinib 100 mg orally twice daily continuously |
| Mismatch repair deficient | Experimental | Drug: CadonilimabCadonilimab 6 mg/kg intravenously on Days 1 and 15 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Adult patient who is aged 18-≤55 years of age
- Has MRI features consistent with a high-grade glioma
- Is planned for standard of care biopsy or surgery to investigate and/or treat this lesion
- ECOG 0-1
- Provides informed written consent
Key exclusion criteria (24 listed)
- Prior radiation or systemic treatment for glioblastoma
- Multi-focal disease not likely to be encompassed within a standard radiotherapy field, infratentorial disease or leptomeningeal disease
- Evidence of significant acute intracranial or intra-tumoural haemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan.
- Serious intercurrent illness, as determined by the treating physician, that would compromise either patient safety or study outcomes.
- Key Eligibility Criteria (Post-Operative Screening)
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 |
|---|---|---|
| LarotrectinibLarotrectinib is a first-in-class, highly selective, oral inhibitor of the tropomyosin receptor kinase (TRK) family of proteins (TRKA, TRKB and TRKC). | Drug | NTRK fusion-positive |
| CadonilimabAK104 is bispecific IgG single chain Fv fragment (ScFv) monoclonal antibody that binds to human programmed cell death 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) | Drug | Mismatch repair deficient |
| PlixorafenibPlixorafenib is a next generation, orally available, small-molecule, selective inhibitor of Class 1 and 2 mutated BRAF. | Drug | BRAF-altered |
Primary outcome
Feasibility of Rapid Molecular Profiling and Matched Targeted Therapy
Time frame: From enrollment to initiation of chemoradiation (pre-treatment period).
To assess the feasibility of performing rapid molecular profiling before chemoradiation and initiating matched targeted therapy in patients with actionable molecular alterations.
8 secondary outcomes
Number and Percentage of Participants Experiencing Adverse Events by CTCAE Grade
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) until 30 days after the end of study treatment.
Efficacy of Induction Targeted Therapy in Newly Diagnosed Glioblastoma
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) until the commencement of the next anti-cancer intervention or death from any cause, whichever occurs first.
Change in Quality of Life Scores as Assessed by the EORTC QLQ-C30 Questionarrie
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) through the end of treatment (EOT), up to 12 months.
Change in Learning and Memory Scores as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis.
Change in Quality of Life Scores as Assessed by the EORTC QLQ-BN20 Questionarrie
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) through the end of treatment (EOT), up to 12 months.
Change in Attention and Working Memory Scores as Assessed by the Wechsler Adult Intelligence Scale Digit Span Test
Time frame: At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis.
Change in Processing Speed as Assessed by Trail Making Test Part A
Time frame: At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis.
Change in Executive Function as Assessed by Verbal Fluency and Trail Making Test Part B
Time frame: At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis.
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 Oct 2026.
- Individual participant dataSharing planned: No. Data sharing to occur at publication.
Related trials for IDH Wildtype Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
RecruitingPhase 1
Anti-GD2 ADC M3554 in Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 2/3
A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Glioblastoma
RecruitingPhase 2
GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma
Glioblastoma, IDH-Wildtype, Progressive Astrocytoma, IDH-Mutant, Grade 4
RecruitingPhase 1/2
A Study of Zedoresertib (Debio 0123) in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Zedoresertib (Debio 0123) in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma
Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Astrocytoma, Grade III
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.
Hui Gan, MBBS, FRACP principal investigator
Olivia Newton-John Cancer Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Larotrectinib, Cadonilimab and Plixorafenib in people with IDH Wildtype Glioblastoma and Glioblastoma (GBM), run by Olivia Newton-John Cancer Research Institute at 1 site 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 24 inclusion and 24 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 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Clinical Project Manager (+61 3 94969369, BRAIDGBM@onjcri.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Rapid Molecular Profiling and Matched Targeted Therapy (time frame: From enrollment to initiation of chemoradiation (pre-treatment period).). 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 Oct 2026.