GlioblastomaPhase 1/2GLIOSUNNCT04443010
Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
A Phase 1/2 study testing Onfekafusp alfa and Temozolomide in people with Glioblastoma, run by Philogen S.p.A. at 1 site in Switzerland.
Trial summary
The purpose of this study is to explore the safety profile and establish a recommended dose (RD) for phase II of the antibody-cytokine fusion protein L19TNF plus standard TMZ chemoradiotherapy in patients with newly diagnosed glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Onfekafusp alfa and Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Jan 2021to Dec 2026
- Phase
- Phase 1/2
- 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 newly diagnosed glioblastoma.
- Karnofsky Performance Score (KPS) ≥ 70%
- 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 (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab), 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: negative pregnancy test for women of childbearing potential (WOCBP)* within 14 days of starting treatment. 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.
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- 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 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
- Prior treatment for glioma, except surgery.
- Inability to undergo contrast-enhanced MRI.
- Intent to be treated with tumor-treating fields prior to progression.
- Known history of allergy to TNF or TMZ, 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 haemoglobin (Hb) < 9.0 g/dl.
- Chronically impaired renal function as indicated by creatinine clearance < 60 mL/min or serum creatinine > 1.5 ULN.
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- Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 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.
- 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.
- Abnormal LVEF or any other abnormalities observed during baseline ECG and echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current or a history of QT/QTc prolongation are excluded.
- Uncontrolled hypertension.
- Known 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 3 weeks of administration of study treatment.
- Known history of tuberculosis.
- 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 chemoradiotherapy. 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.
- Requirement of concurrent therapy with anticoagulants at therapeutic doses.
- 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 vaccination during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
UniversitatSpital USZ
Zurich
Tobias Weiss, MD
About this study
Official title: A Study to Evaluate the Safety and Efficacy of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF Plus Standard Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
The purpose of this study is to explore the safety profile and establish a recommended dose (RD) for phase II of the antibody-cytokine fusion protein L19TNF plus standard TMZ chemoradiotherapy in patients with newly diagnosed glioblastoma.
The study will be conducted in three consecutive parts: a dose finding part to determine the RD of L19TNF in combination with chemoradiotherapy, followed by a signal seeking part that investigates first signs of activity and then an activity evaluation part that studies the efficacy of L19TNF in combination with chemoradiotherapy against chemoradiotherapy alone.
- Conditions
- Glioblastoma
- Being tested
- Onfekafusp alfa, Temozolomide
- Keywords
- Glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onfekafusp alfaDrug
Also called L19TNF
This is an open label phase 1/2/2b study in subjects with newly diagnosed glioblastoma.
The study will be conducted in three consecutive parts: First the dose finding part to determine the RD of L19TNF in combination with chemoradiotherapy, followed by a signal seeking part that investigates first signs of activity and then an activity evaluation part that studies the efficacy of L19TNF in combination with chemoradiotherapy against chemoradiotherapy alone.
TemozolomideDrug
Also called TMZ
Patients will receive radiotherapy and TMZ. Treatment start with chemoradiotherapy is foreseen after surgical resection or biopsy of glioblastoma
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 part: Dose Finding | Experimental | Patients will be treated in cohorts according to a 3+3 study design with standard treatment (consisting of radiotherapy of 60 Gy/30 fractions for 6 weeks plus 75 mg/m2 TMZ (temozolomide) daily (chemoradiotherapy), followed by 4 weeks of treatment break, followed by maintenance treatment with 6 maintenance cycles of TMZ 150-200 mg/m2 on Days 1 to 5 q28) combined with L19TNF at different dose levels on Day 1, 3, 5, 22, 24 and 26 of chemoradiotherapy and on Day 1, 3 and 5 of each 28-day chemotherapy maintenance cycle. Receives: Drug: Onfekafusp alfa |
| Phase 2 part: Signal Seeking | Experimental | 32 patients will receive standard chemoradiotherapy and L19TNF at RD and with the administration scheme established in phase I part of the study. Receives: Drug: Onfekafusp alfa |
| Phase 2b part: Activity Evaluation_control arm | Active comparator | Patients will be randomized 1:1 and treated with either standard chemoradiotherapy and L19TNF as established in phase I part and the phase II part of this study or only chemoradiotherapy (control).
- Arm 2: Patients will receive radiotherapy and TMZ (temozolomide). Receives: Drug: Temozolomide |
| Phase IIb part: Activity Evaluation_treatment arm | Experimental | Patients will be randomized 1:1 and treated with either standard chemoradiotherapy and L19TNF as established in phase I part and the phase II part of this study or only chemoradiotherapy (control).
- Arm 1: Patients will receive radiotherapy, TMZ (temozolomide) and L19TNF. Receives: Drug: Onfekafusp alfa; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
For Phase 1: DLT
Occurrence of dose limiting toxicity (DLT) assessed by frequency and grade of adverse events (AE) according to CTCAE v.5.0.
Measured: For Cohort 1 and Cohort 2 from Day 1 to Day 28 of the maintenance cycle; for Cohort 3, 4 and 5 from Day 1 to Day 42 of the chemoradiotherapy.
For Phase 2: Overall Survival
Overall survival (OS) rate
Measured: From beginning of treatment to 52 weeks
Secondary outcomes (12)
PFS
Progression Free Survival (PFS) will be assessed for all enrolled subjects.
Measured: From the date of enrollment to the date of progression or death for any cause, whichever came first, assessed up to 58 weeks
ORR in CR
Objective Response Rate (ORR): ORR is defined as the rate of patients with complete response (CR) (defined according to iRANO criteria)
Measured: At week 10, at week 22, at week 34, at week 46 and at week 58
ORR in PR
Objective Response Rate (ORR): ORR is defined as the rate of patients with partial response (PR) (defined according to iRANO criteria)
Measured: At week 10, at week 22, at week 34, at week 46 and at week 58
DCR in CR
Disease Control Rate (DCR) is defined as the rate of patients with complete response (CR) (defined according to iRANO criteria)
Measured: At week 10, at week 22, at week 34, at week 46 and at week 58
DCR in PR
Disease Control Rate (DCR) is defined as the rate of patients with partial response (PR) (defined according to iRANO criteria)
Measured: At week 10, at week 22, at week 34, at week 46 and at week 58
DCR in SD
Disease Control Rate (DCR) is defined as the rate of patients with stable disease (SD) (defined according to iRANO criteria)
Measured: At week 10, at week 22, at week 34, at week 46 and at week 58
BORR in CR
Considering the best observed response for any subject, Best Overall Response Rate (BORR) is defined as the rate of complete response (CR) (defined according to iRANO criteria)
Measured: From date of enrollment to week 58
BORR in PR
Considering the best observed response for any subject, Best Overall Response Rate (BORR) is defined as the rate of partial response (PR) (defined according to iRANO criteria)
Measured: From date of enrollment to week 58
BORR in SD
BConsidering the best observed response for any subject, Best Overall Response Rate (BORR) is defined as the rate of stable disease (SD) (defined according to iRANO criteria)
Measured: From date of enrollment to week 58
Safety (AE)
Safety of administration of L19TNF, through an assessed by Common Toxicity Criteria (version 5.0, CTCAE)
Measured: Throughout study completion for each patient, a maximum of 58 weeks for each patient
Safety (SAE)
Safety of administration of L19TNF, assessed by Common Toxicity Criteria (version 5.0, CTCAE)
Measured: Throughout study completion for each patient, a maximum of 58 weeks for each patient
Safety (DILI)
Evaluation of possible Drug Induce Liver Injury, caused by L19TNF, assessed by Common Toxicity Criteria (version 5.0, CTCAE)
Measured: Throughout study completion for each patient, a maximum of 58 weeks for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start20 Jan 2021
- Primary completionOct 2026 (estimated)
- Study completionDec 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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open label phase I/II study in subjects with newly diagnosed glioblastoma. The study will be conducted in three consecutive parts: (i) first the dose finding part to determine the RD of L19TNF in combination with chemoradiotherapy, (ii) followed by a signal seeking part that investigates first signs of activity and (iii) then an activity evaluation part that studies the efficacy of L19TNF in combination with chemoradiotherapy against chemoradiotherapy alone.
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tobias Weiss, PhD, MD, Principal investigator, Universitatspital Zurich - Klinik fur Neurologie & Hirntumorzentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443010
- Sponsor's protocol ID
- PH-L19TNFTMZ-01/20
- Acronym
- GLIOSUN
- Status last verified
- Oct 2023
- First submitted
- 17 Jun 2020
- Last updated
- 10 Oct 2023
- 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF Plus Standard Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT04443010
- Acronym / sponsor ID
- GLIOSUN / PH-L19TNFTMZ-01/20
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jun 2020 (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 profile and establish a recommended dose (RD) for phase II of the antibody-cytokine fusion protein L19TNF plus standard TMZ chemoradiotherapy in patients with newly diagnosed glioblastoma.
The study will be conducted in three consecutive parts: a dose finding part to determine the RD of L19TNF in combination with chemoradiotherapy, followed by a signal seeking part that investigates first signs of activity and then an activity evaluation part that studies the efficacy of L19TNF in combination with chemoradiotherapy against chemoradiotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Open label phase I/II study in subjects with newly diagnosed glioblastoma. The study will be conducted in three consecutive parts: (i) first the dose finding part to determine the RD of L19TNF in combination with chemoradiotherapy, (ii) followed by a signal seeking part that investigates first signs of activity and (iii) then an activity evaluation part that studies the efficacy of L19TNF in combination with chemoradiotherapy against chemoradiotherapy alone.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 part: Dose Finding | Experimental | Drug: Onfekafusp alfaPatients will be treated in cohorts according to a 3+3 study design with standard treatment (consisting of radiotherapy of 60 Gy/30 fractions for 6 weeks plus 75 mg/m2 TMZ (temozolomide) daily (chemoradiotherapy), followed by 4 weeks of treatment break, followed by maintenance treatment with 6 maintenance cycles of TMZ 150-200 mg/m2 on Days 1 to 5 q28) combined with L19TNF at different dose levels on Day 1, 3, 5, 22, 24 and 26 of chemoradiotherapy and on Day 1, 3 and 5 of each 28-day chemotherapy maintenance cycle. |
| Phase 2 part: Signal Seeking | Experimental | Drug: Onfekafusp alfa32 patients will receive standard chemoradiotherapy and L19TNF at RD and with the administration scheme established in phase I part of the study. |
| Phase 2b part: Activity Evaluation_control arm | Active comparator | Drug: TemozolomidePatients will be randomized 1:1 and treated with either standard chemoradiotherapy and L19TNF as established in phase I part and the phase II part of this study or only chemoradiotherapy (control). - Arm 2: Patients will receive radiotherapy and TMZ (temozolomide). |
| Phase IIb part: Activity Evaluation_treatment arm | Experimental | Drug: Onfekafusp alfa, Drug: TemozolomidePatients will be randomized 1:1 and treated with either standard chemoradiotherapy and L19TNF as established in phase I part and the phase II part of this study or only chemoradiotherapy (control). - Arm 1: Patients will receive radiotherapy, TMZ (temozolomide) and L19TNF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, age ≥18.
- Patients with histologically confirmed newly diagnosed glioblastoma.
- Karnofsky Performance Score (KPS) ≥ 70%
- 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 (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab), 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: negative pregnancy test for women of childbearing potential (WOCBP)* within 14 days of starting treatment. 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.
Key exclusion criteria (31 listed)
- Prior treatment for glioma, except surgery.
- Inability to undergo contrast-enhanced MRI.
- Intent to be treated with tumor-treating fields prior to progression.
- Known history of allergy to TNF or TMZ, 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 haemoglobin (Hb) < 9.0 g/dl.
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 |
|---|---|---|
| Onfekafusp alfaAlso: L19TNFThis is an open label phase 1/2/2b study in subjects with newly diagnosed glioblastoma. The study will be conducted in three consecutive parts: First the dose finding part to determine the RD of L19TNF in combination with chemoradiotherapy, followed by a signal seeking part that investigates first signs of activity and then an activity evaluation part that studies the efficacy of L19TNF in combination with chemoradiotherapy against chemoradiotherapy alone. | Drug | Phase 1 part: Dose Finding, Phase 2 part: Signal Seeking, Phase IIb part: Activity Evaluation_treatment arm |
| TemozolomideAlso: TMZPatients will receive radiotherapy and TMZ. Treatment start with chemoradiotherapy is foreseen after surgical resection or biopsy of glioblastoma | Drug | Phase 2b part: Activity Evaluation_control arm, Phase IIb part: Activity Evaluation_treatment arm |
Primary outcome
For Phase 1: DLT
Time frame: For Cohort 1 and Cohort 2 from Day 1 to Day 28 of the maintenance cycle; for Cohort 3, 4 and 5 from Day 1 to Day 42 of the chemoradiotherapy.
Occurrence of dose limiting toxicity (DLT) assessed by frequency and grade of adverse events (AE) according to CTCAE v.5.0.
For Phase 2: Overall Survival
Time frame: From beginning of treatment to 52 weeks
Overall survival (OS) rate
12 secondary outcomes
PFS
Time frame: From the date of enrollment to the date of progression or death for any cause, whichever came first, assessed up to 58 weeks
ORR in CR
Time frame: At week 10, at week 22, at week 34, at week 46 and at week 58
ORR in PR
Time frame: At week 10, at week 22, at week 34, at week 46 and at week 58
DCR in CR
Time frame: At week 10, at week 22, at week 34, at week 46 and at week 58
DCR in PR
Time frame: At week 10, at week 22, at week 34, at week 46 and at week 58
DCR in SD
Time frame: At week 10, at week 22, at week 34, at week 46 and at week 58
BORR in CR
Time frame: From date of enrollment to week 58
BORR in PR
Time frame: From date of enrollment to week 58
BORR in SD
Time frame: From date of enrollment to week 58
Safety (AE)
Time frame: Throughout study completion for each patient, a maximum of 58 weeks for each patient
Safety (SAE)
Time frame: Throughout study completion for each patient, a maximum of 58 weeks for each patient
Safety (DILI)
Time frame: Throughout study completion for each patient, a maximum of 58 weeks for each patient
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 10 Oct 2023.
- 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.
Tobias Weiss, PhD, MD principal investigator
Universitatspital Zurich - Klinik fur Neurologie & Hirntumorzentrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Onfekafusp alfa and Temozolomide in people with Glioblastoma, run by Philogen S.p.A. at 1 site in Switzerland.
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 9 inclusion and 31 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 10 Oct 2023. 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 Switzerland. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
For Phase 1: DLT (time frame: For Cohort 1 and Cohort 2 from Day 1 to Day 28 of the maintenance cycle; for Cohort 3, 4 and 5 from Day 1 to Day 42 of the chemoradiotherapy.). The study lists 2 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 10 Oct 2023.