GliomaPhase 2IMAGLIONCT07120984
A Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma
A Phase 2 study testing L19TNF, L19TNF and TMZ and L19TNF and CCNU in people with Glioma, run by Philogen S.p.A..
Trial summary
The purpose of this study is to explore the safety and efficacy of the antibody-cytokine fusion protein L19TNF alone or in combination with alkylating chemotherapy in patients with recurrent IDH mutant glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- L19TNF, L19TNF and TMZ and L19TNF and CCNU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 30 Jan 2029
- 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
- Age ≥18
- IDH-mutant glioma (according to WHO 2021 classification) at first recurrence or progression after alkylating chemotherapy:
- COHORT 1: Grade ≥2 oligodendroglioma or astrocytoma with planned resection, tumor tissue from prior resection must be available
- COHORT 2A: Grade ≥2 oligodendroglioma
- COHORT 2B1: Grade ≥2 oligodendroglioma previously treated with lomustine as monotherapy or in combination
- COHORT 2B2: Grade ≥2 oligodendroglioma previously treated with temozolomide as monotherapy or in combination
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- COHORT 3A: Grade ≥2 astrocytoma
- COHORT 3B1: Grade ≥2 astrocytoma previously treated with lomustine as monotherapy or in combination
- COHORT 3B2: Grade ≥2 astrocytoma previously treated with temozolomide as monotherapy or in combination
- Measurable disease according to RANO 2.0 criteria.
- Documented IDH1 and/or IDH2 gene mutations detected by immunochemistry or sequencing.
- Karnofsky Performance Status (KPS) ≥ 70%.
- Life expectancy ≥ 3 months.
- Documented negative test for HIV-HBV-HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
- Female patients: female patients must be either documented not Women Of Childbearing Potential (WOCBP)* or must have a negative pregnancy test within 14 days of starting treatment. Additionally WOCBP must agree to use, from the screening to 6 months following the last study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.
- Male patients: male subjects able to father children must agree to use two acceptable methods of contraception throughout the study (e.g. condom with spermicidal gel). Double-barrier contraception is required from the screening to 6 months following the last administration of temozolomide, lomustine or L19TNF.
- Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Who cannot join
- Any therapy for recurrence/progression after alkylating chemotherapy, except resection.
- Therapy for glioma within 4 weeks of start of study treatment.
- Surgical resection of glioma within 4 weeks of start of study treatment.
- Stereotactic biopsy of glioma within 2 weeks of start of study treatment.
- Inability to undergo contrast-enhanced MRI.
- Known history of allergy to TNF or lomustine or temozolomide, any excipient in the study medication or any other intravenously administered human proteins/peptides/antibodies.
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- Absolute neutrophil count (ANC) < 1.5 x 10^9/L; platelets < 100 x 10^9/L or hemoglobin (Hb) < 9.0 g/dl.
- Chronically impaired renal function as indicated by creatinine clearance < 60 mL/min/1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance < 45 mL/min/1.73m2.
- Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 1.5 x ULN).
- INR > 1.5 ULN.
- Any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol, in the opinion of the investigator.
- Active or history of autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent, in the judgement of the investigator.
- History within the last year of cerebrovascular disease and/or acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
- Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria).
- Clinically significant cardiac arrhythmias or requiring permanent medication.
- LVEF < 55% or any other abnormalities observed during baseline ECG and echocardiogram investigations that are considered clinically significant by the investigator. Patients with a marked prolongation of QT/QTc interval (e.g., repeated demonstration of QTc >470 milliseconds using Fredricia's QT correction formula) are excluded.
- Uncontrolled hypertension, defined by systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg.
- Arterial aneurism at high risk of rupture.
- Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).
- Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders.
- Anxiety ≥ CTCAE Grade 3.
- Severe diabetic retinopathy, such as severe non-proliferative retinopathy and proliferative retinopathy.
- Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of study treatment.
- Known history of tuberculosis.
- Pregnancy or breast feeding.
- Requirement of chronic administration of high dose steroids or other immunosuppressant drugs. Subjects must have been either off steroids, or on a stable or decreasing dose ≤ 4 mg daily dexamethasone (or equivalent) for 7 days prior to start of treatment. Limited or occasional use of steroids to treat or prevent acute adverse reactions is not considered an exclusion criterion.
- Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
- Concurrent malignancies other than glioma unless the patient has been disease-free without intervention for at least 2 years.
- Growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.
- Serious, non-healing wound, ulcer or bone fracture.
- Deep vein thrombosis, pulmonary embolism or other acute vascular events within 6 months.
- Anticoagulation therapy with P2Y12 antagonists (e.g., clopidogrel, ticagrelor) and vitamin K antagonists (e.g., phenprocoumon, warfarin).
- Requirement of concurrent use of other anti-cancer treatments or agents other than study medication.
- Any live vaccination within 4 weeks prior to treatment or plan to receive live vaccination during the study.
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
Official title: A Phase II Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma
The purpose of this study is to explore the safety and efficacy of the antibody-cytokine fusion protein L19TNF alone or in combination with alkylating chemotherapy in patients with recurrent IDH mutant glioma.
Read the detailed description
This protocol describes an open label, multi-centric phase 2 study and patients will be treated with L19TNF at 13µg/kg as monotherapy or in combination with alkylating chemotherapy (Lomustine or Temozolamide) in different cohorts:
- COHORT 1: L19TNF monotherapy in perioperative cohort of patients with recurrent astrocytoma or oligodendroglioma,
- COHORT 2A: L19TNF Monotherapy for patients with recurrent oligodendroglioma,
- COHORT 2B1: L19TNF plus TMZ for patients with recurrent oligodendroglioma,
- COHORT 2B2: L9TNF plus CCNU for patients with recurrent oligodendroglioma,
- COHORT 3A: L19TNF Monotherpay for patients with recurrent astrocytoma,
- COHORT 3B1: L19TNF plus TMZ for patients with recurrent astrocytoma,
- COHORT 3B2: L19TNF plus CCNU for patients with recurrent astrocytoma.
Eligibility criteria in this trial are:
- Age ≥18
- IDH-mutant glioma at first recurrence or progression after alkylating chemotherapy:
- COHORT 1: Grade ≥2 oligodendroglioma or astrocytoma with planned resection
- COHORT 2A, 2B1, 2B2: Grade ≥2 oligodendroglioma
- COHORT 3A, 3B1, 3B2: Grade ≥2 astrocytoma
- No therapy for first recurrence or progression after alkylating chemotherapy, except resection.
- Patients must have measurable disease according to RANO 2.0
- Karnofsky Performance Status (KPS) ≥ 70%.
The primary endpoint of the study is the Progression Free Survival Rate at 12 months (PFS-12).
The following secondary endpoints are considered:
- Progression-free survival (PFS)
- Overall response rate (ORR)
- Disease control rate
- Duration of response (DoR)
- Overall survival (OS)
- Safety and tolerability: adverse event (AE), serious AE (SAE), Drug-induced liver injury (DILI), physical examinations, echocardiography, ECG and standard laboratory parameters (hematology, biochemistry liver and urine analysis)
- Human anti-factor antibodies (HAFA)
- popPK
- Conditions
- Glioma
- Being tested
- L19TNF, L19TNF and TMZ, L19TNF and CCNU, L19TNF monotherapy, L19TNF and TMZ in recurrent astrocytoma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L19TNFBiological
1 cycle of TNF before resection and 6 cycles after surgery
L19TNF and TMZBiological
6 cycles of 28 days with L19TNF and TMZ
L19TNF and CCNUBiological
6 cycles of 6 weeks of L19TNF and CCNU every 6 weeks
L19TNF monotherapyBiological
6 cycles of 6 weeks with L19TNF
L19TNF and TMZ in recurrent astrocytomaBiological
6 cycles of 28 days with L19TNF (D1, D3, D5) and temozolomide chemotherapy TMZ (D1-5).
L19TNF and CCNU in recurrent astrocytomaBiological
6 cycles of 6 weeks of L19TNF (D1, D3, D5, D22, D24 and D26) and CCNU (D1) every 6 weeks
L19TNF monothery in recurrent oligodendrogliomaBiological
6 cycles of 6 weeks with L19TNF
| Study group | Role | What they receive |
|---|---|---|
| 1: perioperative cohort of patients with recurrent astrocytoma or oligodendroglioma | Experimental | patients will be treated with 1 cycle (D1, D3 and D5) L19TNF before resection and 4 weeks after surgery Receives: Biological: L19TNF |
| 2A:L19TNF Monotherapy for patients with recurrent oligodendroglioma | Experimental | patients with IDH-mutant oligodendroglioma, WHO Grade 2 or 3 at first progression after radiotherapy and one line of systemic chemotherapy, are treated with up to 6 cycles of 6 weeks with L19TNF Receives: Biological: L19TNF monothery in recurrent oligodendroglioma |
| 2B1: L19TNF plus TMZ for patients with recurrent oligodendroglioma | Experimental | patients with IDH-mutant oligodendroglioma, WHO Grade 2 or 3 at first progression after radiotherapy and one line of systemic CCNU-based chemotherapy, are treated with L19TNF and temozolomide chemotherapy TMZ Receives: Biological: L19TNF and TMZ |
| 2B2: L19TNF plus CCNU for patients with recurrent oligodendroglioma | Experimental | patients with IDH-mutant oligodendroglioma, WHO Grade 2 or 3 at first progression after radiotherapy and one line of systemic temozolomide chemotherapy, are treated with L19TNF and CCNU Receives: Biological: L19TNF and CCNU |
| 3A: L19TNF monotherapy for patients with recurrent astrocytoma | Experimental | patients with IDH-mutant astrocytoma, WHO Grade 2, 3 or 4 at first progression after radiotherapy and one line of systemic chemotherapy, are treated with L19TNF Receives: Biological: L19TNF monotherapy |
| 3B1: L19TNF plus TMZ for patients with recurrent astrocytoma | Experimental | patients with IDH-mutant astrocytoma, WHO Grade 2, 3 or 4 at first progression after radiotherapy and one line of systemic CCNU-based chemotherapy, are treated with L19TNF and temozolomide chemotherapy TMZ Receives: Biological: L19TNF and TMZ in recurrent astrocytoma |
| 3B2: L19TNF plus CCNU for patients with recurrent astrocytoma | Experimental | patients with IDH-mutant astrocytoma, WHO Grade 2, 3 and 4 at first progression after radiotherapy and one line of systemic chemotherapy including temozolomide, are treated with L19TNFand CCNU Receives: Biological: L19TNF and CCNU in recurrent astrocytoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) in according to RECIST v.1.1. The duration is defined beginning from randomization to progression or death from any cause.
Measured: The PFS rate will be assessed at 12 months (PFS-12) in IDH mutant astrocytoma and in oligodendroglioma.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start30 Jan 2026 (estimated)
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Philogen S.p.A.The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120984
- Sponsor's protocol ID
- PH-L19TNFGLIO-02/25
- Acronym
- IMAGLIO
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma
- ClinicalTrials.gov ID
- NCT07120984
- Acronym / sponsor ID
- IMAGLIO / PH-L19TNFGLIO-02/25
- Conditions
- Glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 13 Aug 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.
The purpose of this study is to explore the safety and efficacy of the antibody-cytokine fusion protein L19TNF alone or in combination with alkylating chemotherapy in patients with recurrent IDH mutant glioma.
Detailed description
This protocol describes an open label, multi-centric phase 2 study and patients will be treated with L19TNF at 13µg/kg as monotherapy or in combination with alkylating chemotherapy (Lomustine or Temozolamide) in different cohorts:
- COHORT 1: L19TNF monotherapy in perioperative cohort of patients with recurrent astrocytoma or oligodendroglioma,
- COHORT 2A: L19TNF Monotherapy for patients with recurrent oligodendroglioma,
- COHORT 2B1: L19TNF plus TMZ for patients with recurrent oligodendroglioma,
- COHORT 2B2: L9TNF plus CCNU for patients with recurrent oligodendroglioma,
- COHORT 3A: L19TNF Monotherpay for patients with recurrent astrocytoma,
- COHORT 3B1: L19TNF plus TMZ for patients with recurrent astrocytoma,
- COHORT 3B2: L19TNF plus CCNU for patients with recurrent astrocytoma.
Eligibility criteria in this trial are:
- Age ≥18
- IDH-mutant glioma at first recurrence or progression after alkylating chemotherapy:
- COHORT 1: Grade ≥2 oligodendroglioma or astrocytoma with planned resection
- COHORT 2A, 2B1, 2B2: Grade ≥2 oligodendroglioma
- COHORT 3A, 3B1, 3B2: Grade ≥2 astrocytoma
- No therapy for first recurrence or progression after alkylating chemotherapy, except resection.
- Patients must have measurable disease according to RANO 2.0
- Karnofsky Performance Status (KPS) ≥ 70%.
The primary endpoint of the study is the Progression Free Survival Rate at 12 months (PFS-12).
The following secondary endpoints are considered:
- Progression-free survival (PFS)
- Overall response rate (ORR)
- Disease control rate
- Duration of response (DoR)
- Overall survival (OS)
- Safety and tolerability: adverse event (AE), serious AE (SAE), Drug-induced liver injury (DILI), physical examinations, echocardiography, ECG and standard laboratory parameters (hematology, biochemistry liver and urine analysis)
- Human anti-factor antibodies (HAFA)
- popPK
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1: perioperative cohort of patients with recurrent astrocytoma or oligodendroglioma | Experimental | Biological: L19TNFpatients will be treated with 1 cycle (D1, D3 and D5) L19TNF before resection and 4 weeks after surgery |
| 2A:L19TNF Monotherapy for patients with recurrent oligodendroglioma | Experimental | Biological: L19TNF monothery in recurrent oligodendrogliomapatients with IDH-mutant oligodendroglioma, WHO Grade 2 or 3 at first progression after radiotherapy and one line of systemic chemotherapy, are treated with up to 6 cycles of 6 weeks with L19TNF |
| 2B1: L19TNF plus TMZ for patients with recurrent oligodendroglioma | Experimental | Biological: L19TNF and TMZpatients with IDH-mutant oligodendroglioma, WHO Grade 2 or 3 at first progression after radiotherapy and one line of systemic CCNU-based chemotherapy, are treated with L19TNF and temozolomide chemotherapy TMZ |
| 2B2: L19TNF plus CCNU for patients with recurrent oligodendroglioma | Experimental | Biological: L19TNF and CCNUpatients with IDH-mutant oligodendroglioma, WHO Grade 2 or 3 at first progression after radiotherapy and one line of systemic temozolomide chemotherapy, are treated with L19TNF and CCNU |
| 3A: L19TNF monotherapy for patients with recurrent astrocytoma | Experimental | Biological: L19TNF monotherapypatients with IDH-mutant astrocytoma, WHO Grade 2, 3 or 4 at first progression after radiotherapy and one line of systemic chemotherapy, are treated with L19TNF |
| 3B1: L19TNF plus TMZ for patients with recurrent astrocytoma | Experimental | Biological: L19TNF and TMZ in recurrent astrocytomapatients with IDH-mutant astrocytoma, WHO Grade 2, 3 or 4 at first progression after radiotherapy and one line of systemic CCNU-based chemotherapy, are treated with L19TNF and temozolomide chemotherapy TMZ |
| 3B2: L19TNF plus CCNU for patients with recurrent astrocytoma | Experimental | Biological: L19TNF and CCNU in recurrent astrocytomapatients with IDH-mutant astrocytoma, WHO Grade 2, 3 and 4 at first progression after radiotherapy and one line of systemic chemotherapy including temozolomide, are treated with L19TNFand CCNU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥18
- IDH-mutant glioma (according to WHO 2021 classification) at first recurrence or progression after alkylating chemotherapy:
- Measurable disease according to RANO 2.0 criteria.
- Documented IDH1 and/or IDH2 gene mutations detected by immunochemistry or sequencing.
- Karnofsky Performance Status (KPS) ≥ 70%.
Key exclusion criteria (34 listed)
- Any therapy for recurrence/progression after alkylating chemotherapy, except resection.
- Therapy for glioma within 4 weeks of start of study treatment.
- Surgical resection of glioma within 4 weeks of start of study treatment.
- Stereotactic biopsy of glioma within 2 weeks of start of study treatment.
- Inability to undergo contrast-enhanced MRI.
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 |
|---|---|---|
| L19TNF1 cycle of TNF before resection and 6 cycles after surgery | Biological | 1: perioperative cohort of patients with recurrent astrocytoma or oligodendroglioma |
| L19TNF and TMZ6 cycles of 28 days with L19TNF and TMZ | Biological | 2B1: L19TNF plus TMZ for patients with recurrent oligodendroglioma |
| L19TNF and CCNU6 cycles of 6 weeks of L19TNF and CCNU every 6 weeks | Biological | 2B2: L19TNF plus CCNU for patients with recurrent oligodendroglioma |
| L19TNF monotherapy6 cycles of 6 weeks with L19TNF | Biological | 3A: L19TNF monotherapy for patients with recurrent astrocytoma |
| L19TNF and TMZ in recurrent astrocytoma6 cycles of 28 days with L19TNF (D1, D3, D5) and temozolomide chemotherapy TMZ (D1-5). | Biological | 3B1: L19TNF plus TMZ for patients with recurrent astrocytoma |
| L19TNF and CCNU in recurrent astrocytoma6 cycles of 6 weeks of L19TNF (D1, D3, D5, D22, D24 and D26) and CCNU (D1) every 6 weeks | Biological | 3B2: L19TNF plus CCNU for patients with recurrent astrocytoma |
| L19TNF monothery in recurrent oligodendroglioma6 cycles of 6 weeks with L19TNF | Biological | 2A:L19TNF Monotherapy for patients with recurrent oligodendroglioma |
Primary outcome
Progression-free survival (PFS)
Time frame: The PFS rate will be assessed at 12 months (PFS-12) in IDH mutant astrocytoma and in oligodendroglioma.
Progression-free survival (PFS) in according to RECIST v.1.1. The duration is defined beginning from randomization to progression or death from any cause.
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 13 Aug 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L19TNF, L19TNF and TMZ and L19TNF and CCNU in people with Glioma, run by Philogen S.p.A..
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 18 inclusion and 34 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 13 Aug 2025. 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 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 Teresa Hemmerle, PhD (+390577017816, regulatory@philogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: The PFS rate will be assessed at 12 months (PFS-12) in IDH mutant astrocytoma and in oligodendroglioma.). 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 13 Aug 2025.