GlioblastomaPhase 2GLIOSTELLANCT06336291
A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence
A Phase 2 study testing L19TNF and Lomustine in people with Glioblastoma, run by Philogen S.p.A. at 9 sites in United States.
Trial summary
The trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at progression or recurrence Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- L19TNF and Lomustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 9 sitesUnited States
- Study dates
- 22 May 2024to Jun 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
- Male or female, age ≥18.
- Patients with histologically confirmed glioblastoma per 2021 WHO classification progression according to RANO criteria.
- For operated patients, the histological report must document glioblastoma recurrence and a new MRI will need to be done at 3-5 weeks after surgery (directly before study treatment start). Study treatment will need to start minimum 4 weeks after surgery.
- MGMT promotor status known.
- Karnofsky Performance Status (KPS) ≥ 60%.
- 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 (HBV-DNA is not required for patients with documented vaccination report). 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.
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- 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 and until 6 months after last study drug administration (e.g. condom with spermicidal gel). Double-barrier contraception is required.
- 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 the scheduled visits, treatment plan, laboratory tests and other study procedures.
- Women of childbearing potential (WOCBP) are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
Who cannot join
- Inability to undergo contrast-enhanced MRI.
- Anti-cancer treatment with radiation therapy, chemotherapy, targeted therapies, immunotherapy, hormones, tumor treating fields or other antitumor therapies within 4 weeks prior to study treatment start.
- Subjects who participated in an investigational drug or device study within 4 weeks prior to study treatment start.
- Grade ≥ 4 myelotoxicity with previous treatment of alkylating agents (e.g., TMZ, CCNU).
- Previous treatment with Bevacizumab.
- Previous treatment with L19TNF.
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- Previous treatment in the PH-L19TNFCCNU-02/20 study.
- Known history of allergy to TNF, any excipient in the study medication or any other intravenously administered human proteins/peptides/antibodies.
- 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 immune-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 as 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.
- Known arterial aneurism at high risk of rupture.
- Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification)
- 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 3 weeks of administration of study treatment.
- Known active or latent tuberculosis (TB).
- Pregnancy or breast feeding.
- Requirement of chronic administration of high dose corticosteroids or other immunosuppressant drugs. Subjects must have been either off corticosteroids, 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 corticosteroids 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 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 recent live vaccination within 4 weeks prior to treatment or plan to receive live vaccination during the study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215
University of Virginia (UVA)
Charlottesville, Virginia, 22903
Northwestern Memorial Hospital
Chicago, Illinois, 60611
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Dose Optimization Study for L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence
The trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at progression or recurrence
Read the detailed description
The present study is a randomized, open-label, non-controlled phase II study in patients with glioblastoma at any progression/recurrence (first and later).
Overall, 90 subjects will be enrolled and parallel assigned in a 1:1 fashion to one of six treatment arms (from A to F) of 15 patients each.
Each arm has a different combination of L19TNF (7 μg/kg or 10 μg/kg or 13 μg/kg) and lomustine at different dose levels (90 or 110 mg/m2).
Treatment is based on a 42-day cycle for up to a maximum of 6 cycles.
This is an open-label study, so there is no blinding.
Patients who successfully complete the screening evaluations and are eligible for participation in the study will be enrolled and randomly assigned (1:1:1:1:1:1) to either of the six parallel treatment arms.
To maintain an appropriate balance between the six treatment arms and avoid undesired confounding effect of different factors, patients will be randomized in accordance with the following strata:
- MGMT status
- Steroid administration
- Previous systemic therapy treatment for progression
A randomization list will be prepared for each stratum using permuted block, the block sizes will be chosen randomly from different, pre-specified sizes with an equal treatment allocation ratio. The labels for the arms are assigned randomly within each block (fixed seed). The obtained final list is sorted by block together with the progressive enrollment number for the patients.
The primary objective of this study is to select the optimal regimen of L19TNF in combination with lomustine, that maximizes effects on clinical parameters and minimizes the probability of moderate to severe adverse events, among six (three L19TNF doses x two lomustine doses) combination schedules for the treatment of patient with progressing or recurrent glioblastoma.
Primary endpoints include Safety (Incidence of adverse Events (AEs), Serious Adverse Events (SAEs) and Drug-Induced Liver Injury (DILI), standard laboratory assessments, ECG, ECHO and physical examination according to CTCAE v.5.0) and Efficacy (Survival rate at 12 months).
The secondary objective of this study is to further evaluate safety, efficacy, exposure, dose-response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels to determine the best dose regimen for further studies.
During the conduct of the study the safety information collected will be routinely reviewed by the Data and Safety Monitoring Board (DSMB) in order to identify possible safety concerns.
If the probability in a treatment arm that the development of unacceptable toxicity rate exceeds 33 % is equal or higher than 80%, the recruitment to this treatment arm will be interrupted and the DSMB will be informed to assess the events and relationship to the study treatment. The DSMB may then recommend to re-start recruitment again for the treatment arm or permanently suspend it.
In case of a treatment-related death, recruitment will be suspended for all treatment arms until the Data and Safety Monitoring Board (DSMB) has reviewed the event and recommended to restart
- Conditions
- Glioblastoma
- Being tested
- L19TNF, Lomustine
- Keywords
- L19TNF, Glioblastoma at progression
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L19TNFDrug
Also called onfekafusp alfa
7 μg/kg
L19TNFDrug
Also called onfekafusp alfa
10 μg/kg
L19TNFDrug
Also called onfekafusp alfa
13 μg/kg
LomustineDrug
90 mg/m2
LomustineDrug
110 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Patients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles. Receives: Drug: L19TNF; Drug: Lomustine |
| Arm B | Experimental | Patients will be treated with on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles Receives: Drug: L19TNF; Drug: Lomustine |
| Arm C | Experimental | Patients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles. Receives: Drug: L19TNF; Drug: Lomustine |
| Arm D | Experimental | Patients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles. Receives: Drug: L19TNF; Drug: Lomustine |
| Arm E | Experimental | Patients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles. Receives: Drug: L19TNF; Drug: Lomustine |
| Arm F | Experimental | Patients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles. Receives: Drug: L19TNF; Drug: Lomustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Occurence of AEs according to CTCAE v.5.0
Measured: From the screening, throughout the study, until demonstration of confirmed disease progression, treatment begins with another anti-cancer agent or surgery, or for a minimum of 12 months
Serious Adverse Events
Occurence of SAEs according to CTCAE v.5.0
Measured: From the screening, throughout the study, until demonstration of confirmed disease progression, treatment begins with another anti-cancer agent or surgery, or for a minimum of 12 months
Unacceptable Toxicity
Occurence of Unacceptable Toxicity according to CTCAE v.5.0
Measured: From the start of treatment up to 3 months
DILI assessment
Occurence of DILI according to CTCAE v.5.0
Measured: From the screening, throughout the study, until demonstration of confirmed disease progression, treatment begins with another anti-cancer agent or surgery, or for a minimum of 12 months
Survival
Survival rate at 12 months
Measured: From enrollment to death from any cause, for a minimum of 12 months
Secondary outcomes (10)
Overall Survival
Measured: From enrollment to death from any cause, for a minimum of 12 months
Progression Free Survival
Measured: From enrollment to the date of progression or death from any cause, whichever came first, for a minimum of 12 months
Objective Response Rate
The rate of patients achieving Complete Response (CR) or Partial Response (PR) defined according to RANO criteria
Measured: From enrollment to death from any cause, for a minimum of 12 months
Disease Control Rate
The rate of patients achieving complete (CR), partial (PR) and stable response (SD)
Measured: From enrollment to death from any cause, for a minimum of 12 months
Duration of Response
Measured: From enrollment to the date of progression or death from any cause, whichever came first, for a minimum of 12 months
Time to reach maximum drug concentration [Tmax]
Pharmacokinetics assessment of L19TNF through blood sampling
Measured: From the start of treatment up to 9 months
Terminal half-life [t1/2]
Pharmacokinetics assessment of L19TNF through blood sampling
Measured: From the start of treatment up to 9 months
Area under the drug concentration-time curve, extrapolated to infinity [AUC]
Pharmacokinetics assessment of L19TNF through blood sampling
Measured: From the start of treatment up to 9 months
Maximum drug concentration [Cmax]
Pharmacokinetics assessment of L19TNF through blood sampling
Measured: From the start of treatment up to 9 months
Human anti-fusion protein antibodies (HAFA) levels against L19TNF
Determination of the formation of Human Anti-Fusion protein Antibodies (HAFA) against L19TNF
Measured: From the start of treatment to the date of progression or death for any cause, whichever come first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start22 May 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 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
- NCT06336291
- Sponsor's protocol ID
- PH-L19TNFLOM-01/23
- Acronym
- GLIOSTELLA
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Optimization Study for L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence
- ClinicalTrials.gov ID
- NCT06336291
- Acronym / sponsor ID
- GLIOSTELLA / PH-L19TNFLOM-01/23
- Conditions
- Glioblastoma
- Keywords
- L19TNF, Glioblastoma at progression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 22 May 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 28 Mar 2024 (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 trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at progression or recurrence
Detailed description
The present study is a randomized, open-label, non-controlled phase II study in patients with glioblastoma at any progression/recurrence (first and later).
Overall, 90 subjects will be enrolled and parallel assigned in a 1:1 fashion to one of six treatment arms (from A to F) of 15 patients each.
Each arm has a different combination of L19TNF (7 μg/kg or 10 μg/kg or 13 μg/kg) and lomustine at different dose levels (90 or 110 mg/m2).
Treatment is based on a 42-day cycle for up to a maximum of 6 cycles.
This is an open-label study, so there is no blinding.
Patients who successfully complete the screening evaluations and are eligible for participation in the study will be enrolled and randomly assigned (1:1:1:1:1:1) to either of the six parallel treatment arms.
To maintain an appropriate balance between the six treatment arms and avoid undesired confounding effect of different factors, patients will be randomized in accordance with the following strata:
- MGMT status
- Steroid administration
- Previous systemic therapy treatment for progression
A randomization list will be prepared for each stratum using permuted block, the block sizes will be chosen randomly from different, pre-specified sizes with an equal treatment allocation ratio. The labels for the arms are assigned randomly within each block (fixed seed). The obtained final list is sorted by block together with the progressive enrollment number for the patients.
The primary objective of this study is to select the optimal regimen of L19TNF in combination with lomustine, that maximizes effects on clinical parameters and minimizes the probability of moderate to severe adverse events, among six (three L19TNF doses x two lomustine doses) combination schedules for the treatment of patient with progressing or recurrent glioblastoma.
Primary endpoints include Safety (Incidence of adverse Events (AEs), Serious Adverse Events (SAEs) and Drug-Induced Liver Injury (DILI), standard laboratory assessments, ECG, ECHO and physical examination according to CTCAE v.5.0) and Efficacy (Survival rate at 12 months).
The secondary objective of this study is to further evaluate safety, efficacy, exposure, dose-response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels to determine the best dose regimen for further studies.
During the conduct of the study the safety information collected will be routinely reviewed by the Data and Safety Monitoring Board (DSMB) in order to identify possible safety concerns.
If the probability in a treatment arm that the development of unacceptable toxicity rate exceeds 33 % is equal or higher than 80%, the recruitment to this treatment arm will be interrupted and the DSMB will be informed to assess the events and relationship to the study treatment. The DSMB may then recommend to re-start recruitment again for the treatment arm or permanently suspend it.
In case of a treatment-related death, recruitment will be suspended for all treatment arms until the Data and Safety Monitoring Board (DSMB) has reviewed the event and recommended to restart
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: L19TNF, Drug: LomustinePatients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles. |
| Arm B | Experimental | Drug: L19TNF, Drug: LomustinePatients will be treated with on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles |
| Arm C | Experimental | Drug: L19TNF, Drug: LomustinePatients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles. |
| Arm D | Experimental | Drug: L19TNF, Drug: LomustinePatients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles. |
| Arm E | Experimental | Drug: L19TNF, Drug: LomustinePatients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles. |
| Arm F | Experimental | Drug: L19TNF, Drug: LomustinePatients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female, age ≥18.
- Patients with histologically confirmed glioblastoma per 2021 WHO classification progression according to RANO criteria.
- For operated patients, the histological report must document glioblastoma recurrence and a new MRI will need to be done at 3-5 weeks after surgery (directly before study treatment start). Study treatment will need to start minimum 4 weeks after surgery.
- MGMT promotor status known.
- Karnofsky Performance Status (KPS) ≥ 60%.
Key exclusion criteria (35 listed)
- Inability to undergo contrast-enhanced MRI.
- Anti-cancer treatment with radiation therapy, chemotherapy, targeted therapies, immunotherapy, hormones, tumor treating fields or other antitumor therapies within 4 weeks prior to study treatment start.
- Subjects who participated in an investigational drug or device study within 4 weeks prior to study treatment start.
- Grade ≥ 4 myelotoxicity with previous treatment of alkylating agents (e.g., TMZ, CCNU).
- Previous treatment with Bevacizumab.
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 |
|---|---|---|
| L19TNFAlso: onfekafusp alfa7 μg/kg | Drug | Arm A, Arm B |
| L19TNFAlso: onfekafusp alfa10 μg/kg | Drug | Arm C, Arm D |
| L19TNFAlso: onfekafusp alfa13 μg/kg | Drug | Arm E, Arm F |
| Lomustine90 mg/m2 | Drug | Arm A, Arm C, Arm E |
| Lomustine110 mg/m2 | Drug | Arm B, Arm D, Arm F |
Primary outcome
Adverse Events
Time frame: From the screening, throughout the study, until demonstration of confirmed disease progression, treatment begins with another anti-cancer agent or surgery, or for a minimum of 12 months
Occurence of AEs according to CTCAE v.5.0
Serious Adverse Events
Time frame: From the screening, throughout the study, until demonstration of confirmed disease progression, treatment begins with another anti-cancer agent or surgery, or for a minimum of 12 months
Occurence of SAEs according to CTCAE v.5.0
Unacceptable Toxicity
Time frame: From the start of treatment up to 3 months
Occurence of Unacceptable Toxicity according to CTCAE v.5.0
DILI assessment
Time frame: From the screening, throughout the study, until demonstration of confirmed disease progression, treatment begins with another anti-cancer agent or surgery, or for a minimum of 12 months
Occurence of DILI according to CTCAE v.5.0
Survival
Time frame: From enrollment to death from any cause, for a minimum of 12 months
Survival rate at 12 months
10 secondary outcomes
Overall Survival
Time frame: From enrollment to death from any cause, for a minimum of 12 months
Progression Free Survival
Time frame: From enrollment to the date of progression or death from any cause, whichever came first, for a minimum of 12 months
Objective Response Rate
Time frame: From enrollment to death from any cause, for a minimum of 12 months
Disease Control Rate
Time frame: From enrollment to death from any cause, for a minimum of 12 months
Duration of Response
Time frame: From enrollment to the date of progression or death from any cause, whichever came first, for a minimum of 12 months
Time to reach maximum drug concentration [Tmax]
Time frame: From the start of treatment up to 9 months
Terminal half-life [t1/2]
Time frame: From the start of treatment up to 9 months
Area under the drug concentration-time curve, extrapolated to infinity [AUC]
Time frame: From the start of treatment up to 9 months
Maximum drug concentration [Cmax]
Time frame: From the start of treatment up to 9 months
Human anti-fusion protein antibodies (HAFA) levels against L19TNF
Time frame: From the start of treatment to the date of progression or death for any cause, whichever come first
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 21 Apr 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 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 L19TNF and Lomustine in people with Glioblastoma, run by Philogen S.p.A. at 9 sites in United States.
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 12 inclusion and 35 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: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From the screening, throughout the study, until demonstration of confirmed disease progression, treatment begins with another anti-cancer agent or surgery, or for a minimum of 12 months). The study lists 5 primary outcomes in all. 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 21 Apr 2026.