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GlioblastomaPhase 1/2GLORIANCT04121455

Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients

A Phase 1/2 study testing Olaptesed pegol, Radiotherapy and Bevacizumab in people with Glioblastoma, run by TME Pharma AG at 6 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to obtain first, exploratory information on the safety and efficacy of (i) olaptesed pegol in combination with radiation therapy in patients with newly diagnosed glioblastoma of unmethylated MGMT promoter status either not amenable to resection (biopsy only) or after incomplete tumor… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Olaptesed pegol, Radiotherapy and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
6 sitesGermany
Study dates
12 Sep 2019to Dec 2028
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

  • Written informed consent
  • Age ≥18 years
  • Patient agreement to diagnostic and scientific work-up of glioblastoma tissue obtained during the preceding surgery or biopsy
  • Patient agrees to subcutaneous port implantation
  • Newly diagnosed, histologically confirmed, supratentorial WHO grade IV glioblastoma
  • Status post biopsy or incomplete resection
Show all 52Show fewer
  • Unmethylated MGMT promoter status
  • Maximum Eastern Cooperative Oncology Group (ECOG) score 2
  • Estimated minimum life expectancy 3 months
  • Stable or decreasing dose of corticosteroids during the week prior to inclusion
  • The following laboratory parameters should be within the ranges specified:
  • Total bilirubin ≤ 1.5 x upper limit normal (ULN)
  • Creatinine ≤ 1.5 x ULN or glomerular filtration rate ≥ 60 mL/min/1.73m²
  • ALT (alanine transaminase) ≤ 3 x ULN
  • AST (aspartate transaminase) ≤ 3 x ULN
  • Female patients of child-bearing potential must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly such as contraceptive implants, vaginal rings, sterilization, or sexual abstinence)" during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations)
  • Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP
  • Written informed consent
  • Age ≥ 18 years
  • Patient agreement to diagnostic and scientific work-up of glioblastoma tissue obtained during the preceding surgery or biopsy (e.g., MGMT promoter analysis, cytogenetic markers such as IDH-1 mutations, etc.)
  • Patient agrees to subcutaneous port implantation
  • Newly diagnosed, histologically confirmed, supratentorial WHO grade IV glioblastoma
  • a) Status post biopsy or incomplete (detectable residual tumor as per postoperative T1-weighted, contrast-enhanced MRI scan) or complete resection (Arm A) OR b) Status post complete resection (Arm B) OR c) Status post complete or incomplete resection (circumscribed enhancing tumor ≤ 5.0 cm in largest diameter as per postoperative T1-weighted, contrast-enhanced MRI scan) (Arm C)
  • Unmethylated MGMT promoter status
  • Maximum Eastern Cooperative Oncology Group (ECOG) score 2
  • Estimated minimum life expectancy 3 months
  • Stable or decreasing dose of corticosteroids during the week prior to inclusion
  • The following laboratory parameters should be within the ranges specified:
  • Total bilirubin ≤ 1.5 x upper limit normal (ULN)
  • Creatinine ≤ 1.5 x ULN or glomerular filtration rate ≥ 60 mL/min/1.73m²
  • ALT (alanine transaminase) ≤ 3 x ULN
  • AST (aspartate transaminase) ≤ 3 x ULN
  • Female patients of child-bearing potential must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly such as contraceptive implants, vaginal rings, sterilization, or sexual abstinence) during and for 3 months (6 months Arm A, 4 months Arm C) following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations)
  • Male patients must use an effective barrier method of contraception during study and for 3 months (6 months Arm A, 4 months Arm C) following the last dose if sexually active with a FCBP
  • Written informed consent
  • Age ≥ 18 years
  • Patient agreement to diagnostic and scientific work-up of glioblastoma tissue obtained during the preceding surgery (e.g., MGMT promoter analysis, cytogenetic markers such as IDH-1 mutations, etc.)
  • Patient agrees to subcutaneous port implantation
  • Newly diagnosed, histologically confirmed, supratentorial WHO grade 4 glioblastoma, IDH-wildtype according to the 2021 World Health Organization Criteria for CNS tumors
  • Status post incomplete resection (detectable residual tumor as per postoperative T1-weighted, contrast-enhanced MRI scan)
  • Unmethylated MGMT promoter status
  • Maximum Eastern Cooperative Oncology Group (ECOG) score 2
  • Estimated minimum life expectancy 3 months
  • Stable or decreasing dose of corticosteroids during the week prior to inclusion
  • The following laboratory parameters should be within the ranges specified:
  • Total bilirubin ≤ 1.5 x upper limit normal (ULN)
  • Body surface area (BSA) adjusted glomerular filtration rate (GFR) ≥ 60 mL/min (BSA-adjusted eGFR CKD-EPI (mL/min) = [eGFR CKD-EPI (mL/min/1.73 m²) x BSA (m²)]/ 1.73; BSA calculated by Du Bois formula)
  • Alanine transaminase (ALT) ≤ 3 x ULN
  • Aspartate transaminase (AST) ≤ 3 x ULN
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L and platelet count ≥ 100 x 10^9/L
  • Female patients of child-bearing potential (FCBP) must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly such as contraceptive implants, vaginal rings, sterilization, or sexual abstinence) during and for 6 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations)
  • Male patients must use an effective barrier method of contraception during study and for 6 months following the last dose if sexually active with a FCBP

Who cannot join

  • Inability to understand and collaborate throughout the study or inability or unwillingness to comply with study requirements
  • Participation in any clinical research study with administration of an investigational drug or therapy within 30 days from screening visit or observation period of competing studies
  • Contra-indication or known hypersensitivity to MRI contrast agents, olaptesed pegol or polyethylene glycol
  • Cytostatic therapy (chemotherapy) within the past 5 years
  • History of other cancers (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for ≥ 5 years)
  • Clinically significant or uncontrolled cardiovascular disease
Show all 107Show fewer
  • Prior radiotherapy to the head
  • Any other previous or concomitant experimental glioblastoma treatments
  • Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles
  • Pregnancy or lactation
  • Uncontrolled intercurrent illness; patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator\'s opinion, interfere with the conduct of the study or study evaluations
  • Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma
  • Prior enrolment into this study
  • Inability to understand and collaborate throughout the study or inability or unwillingness to comply with study requirements
  • Participation in any clinical research study with administration of an investigational drug or therapy within 30 days from screening visit or observation period of competing studies
  • Contra-indication or known hypersensitivity to MRI contrast agents, bevacizumab (Arm A only) olaptesed pegol or polyethylene glycol
  • Planned hypofractionated radiotherapy
  • Cytostatic therapy (chemotherapy) within the past 5 years
  • History of other cancers (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for ≥ 5 years)
  • Secondary malignancy which is currently active
  • Clinically significant or uncontrolled cardiovascular disease, including
  • Myocardial infarction in the previous 12 months
  • Uncontrolled angina
  • Congestive heart failure (New York Heart Association functional classification of ≥2)
  • Diagnosed or suspected congenital long QT syndrome
  • QTc prolongation on an electrocardiogram prior to entry (QTc(Bazett) \>470 ms)
  • Uncontrolled hypertension (blood pressure ≥ 160/95 mmHg)
  • Heart rate \<50/min on the baseline electrocardiogram
  • History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes)
  • Cerebrovascular accident
  • Prior radiotherapy to the head
  • Any other previous or concomitant experimental glioblastoma treatments
  • Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles
  • Patients with a history of arterial or venous thrombosis (or any other disease) requiring permanent intake of anticoagulants (Arm A only)
  • Pregnancy or lactation
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), diabetes mellitus, or subjects with either of the following: fasting blood glucose (FBG defined as fasting for at least 8 hours) ≥ 200 mg/dL (7.0 mmol/L), or HbA1c ≥ 8%, chronic renal disease, pancreatitis, chronic pulmonary disease, auto-immune diseases, or psychiatric illness/social situations that would limit compliance with study requirements. Patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator\'s opinion, interfere with the conduct of the study or study evaluations
  • Prolongation of coagulation factors ≥ 2.5 x ULN (Arm A only)
  • Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma
  • Prior enrolment into this study
  • Inability to understand and collaborate throughout the study or inability or unwillingness to comply with study requirements
  • Participation in any clinical research study with administration of an investigational drug or therapy within 30 days from screening visit or observation period of competing studies
  • Contra-indication or known hypersensitivity to MRI contrast agents olaptesed pegol or polyethylene glycol or pembrolizumab (≥ Grade 3)
  • Biopsy-only of GBM with less than 20% of tumor removed
  • Presence of extracranial metastatic or leptomeningeal disease
  • Severe hypersensitivity (≥ Grade 3) to other monoclonal antibodies
  • Receiving immunosuppressive therapy
  • Previous or current treatment with an anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PDL2 agent
  • Planned hypofractionated radiotherapy
  • Cytostatic therapy (chemotherapy) within the past 5 years
  • History of other cancers or secondary malignancy which is currently active (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for ≥ 5 years)
  • Clinically significant or uncontrolled cardiovascular disease, including
  • Myocardial infarction in the previous 12 months
  • Uncontrolled angina
  • Congestive heart failure (New York Heart Association functional classification of ≥2)
  • Diagnosed or suspected congenital long QT syndrome
  • QTc prolongation on an electrocardiogram prior to entry (QTc(Bazett) \>470 ms)
  • Uncontrolled hypertension (blood pressure ≥ 160/95 mmHg)
  • Heart rate \<50/min on the baseline electrocardiogram
  • History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes)
  • Cerebrovascular accident
  • Prior radiotherapy to the head
  • Evidence of acute intracranial / intra-tumoral hemorrhage
  • Any other previous or concomitant experimental glioblastoma treatments
  • Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles
  • Pregnancy or lactation
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), diabetes mellitus, or subjects with either of the following: fasting blood glucose (FBG defined as fasting for at least 8 hours) ≥ 200 mg/dL (7.0 mmol/L), or HbA1c ≥ 8%, chronic renal disease, pancreatitis, chronic pulmonary disease, auto-immune diseases or psychiatric illness/social situations that would limit compliance with study requirements. Patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator's opinion, interfere with the conduct of the study or study evaluations.
  • Received a live vaccine within 30 days prior to the first dose of study drug.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Previously treated brain metastases may participate provided these remain stable
  • Known history of HIV infection, hepatitis B or hepatitis C infection
  • Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or current pneumonitis / interstitial lung disease
  • Immunodeficiency diagnosis or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone) or any other form of immunosuppressive therapy
  • High dose of corticosteroids (≥ 4mg/day of dexamethasone or equivalent for at least 3 consecutive days) within two weeks prior to the first dose of study drug
  • Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma
  • Prior enrolment into this study
  • Patients with tumors harboring IDH mutations
  • Inability to understand and collaborate throughout the study or inability or unwillingness to comply with study requirements
  • Participation in any clinical research study with administration of an investigational drug or therapy within 30 days prior to screening visit or observation period of competing studies
  • Contra-indication or known hypersensitivity to MRI contrast agents, bevacizumab, olaptesed pegol or polyethylene glycol
  • Planned hypofractionated radiotherapy
  • Chemotherapy (cytotoxic/cytostatic) within the past 5 years
  • History of other cancers (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for ≥ 5 years)
  • Secondary malignancy which is currently active
  • Clinically significant or uncontrolled cardiovascular disease, including
  • Myocardial infarction in the previous 12 months
  • Uncontrolled angina
  • Congestive heart failure (New York Heart Association functional classification of ≥2)
  • Diagnosed or suspected congenital long QT syndrome
  • QTc prolongation on the electrocardiogram prior to inclusion (QTc(Bazett) \>470 ms)
  • Uncontrolled hypertension (blood pressure ≥ 160/95 mmHg)
  • Heart rate \<50/min on the electrocardiogram prior to inclusion
  • History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes)
  • Cerebrovascular accident
  • Prior radiotherapy to the head
  • Any other previous or concomitant experimental glioblastoma treatments
  • Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles
  • Patients with a history of arterial or venous thrombosis (or any other disease) requiring permanent intake of anticoagulants
  • Pregnancy or lactation
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), diabetes mellitus, or patients with either of the following: fasting blood glucose (FBG defined as fasting for at least 8 hours) ≥ 200 mg/dL (7.0 mmol/L), or HbA1c ≥ 8%, chronic renal disease, pancreatitis, chronic pulmonary disease, auto-immune diseases or psychiatric illness/social situations that would limit compliance with study requirements. Patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator's opinion, interfere with the conduct of the study or study evaluations.
  • Prolongation of coagulation factors ≥ 2.5 x ULN
  • Treatment not initiated within 6 weeks after surgery of glioblastoma
  • Prior enrolment into this study
  • History of hypersensitivity to dacarbazine (DTIC)
  • History of hypersensitivity reaction (such as urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis, and Stevens-Johnson syndrome) to temozolomide or any of its components
  • Severe myelosuppression (ANC \<1.5 x 10^9/L and platelet count \<100 x 10^9/L)
  • Major surgery within 28 days prior to treatment start
  • Non-healing wounds

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Klinik und Poliklinik für Neurologie Schwerpunkt Klinische Neuroonkologie

    Bonn

  • Klinik für Neurologie

    Essen

  • Klinik für Strahlentherapie und Radioonkologie

    Leipzig

  • Klinik für Strahlentherapie und Radioonkologie

    Mannheim

  • Klinik für Neurologie mit Institut für Translationale Neurologie

    Münster

  • Abteilung Neurologie mit interdisziplinärem Schwerpunkt Neuroonkologie

    Tübingen

Other trials in Germany

About this study

Official title: Single-arm, Dose-escalation Phase 1/2 Study of Olaptesed Pegol (NOX-A12) in Combination With Irradiation in Inoperable or Partially Resected First-line Glioblastoma Patients With Unmethylated MGMT Promoter With a Multiple-arm Expansion Group

The purpose of this study is to obtain first, exploratory information on the safety and efficacy of (i) olaptesed pegol in combination with radiation therapy in patients with newly diagnosed glioblastoma of unmethylated MGMT promoter status either not amenable to resection (biopsy only) or after incomplete tumor resection, and (ii) olaptesed pegol in combination with radiation therapy and bevacizumab in patients with newly diagnosed glioblastoma of unmethylated MGMT promoter status either not amenable to resection (biopsy only) or after incomplete or complete tumor resection.

Further arms are included (i) to establish safety for the combination of olaptesed pegol at three different doses in addition to radiotherapy and bevacizumab, (ii) to explore the benefit of combining olaptesed pegol at different dose levels with bevacizumab in order to define the doses to move forward into a subsequent randomized dose-finding study, (iii) to explore the contribution of the therapy components olaptesed pegol and bevacizumab to patient benefit and (iv) to put the clinical outcome of these treatment regimens into perspective with the standard of care treatment with temozolomide and radiotherapy.

Conditions
Glioblastoma
Being tested
Olaptesed pegol, Radiotherapy, Bevacizumab, Pembrolizumab, Temozolomide (TMZ)
Keywords
Glioblastoma, NOX-A12, Olaptesed pegol, Spiegelmer, Stromal cell-derived factor-1 (SDF-1), CXCL12, Radiation, MGMT promoter, Brain tumor, Radiotherapy, Brain cancer, Tumor microenvironment, Bevacizumab
Medical subject headings
Glioblastoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olaptesed pegolDrug

    Also called NOX-A12

    Olaptesed pegol continuous i.v. administration

  • RadiotherapyRadiation

    Radiotherapy in weeks 1-6; cumulative dose of 60 Gy in 2 Gy fractions

  • BevacizumabDrug

    Bevacizumab every 2 weeks i.v. infusion

  • PembrolizumabDrug

    Also called KEYTRUDA

    Pembrolizumab every 3 weeks i.v. for 26 weeks

  • Temozolomide (TMZ)Drug

    oral treatment according to current SPC

Study groups in NCT04121455
Study groupRoleWhat they receive
Cohort 1: 200 mg Olaptesed pegol + RadiotherapyExperimentalolaptesed pegol weekly for 26 weeks administered i.v. by continuous infusion plus radiotherapy during weeks 1-6
Receives: Drug: Olaptesed pegol; Radiation: Radiotherapy
Cohort 2: 400 mg Olaptesed pegol + RadiotherapyExperimentalolaptesed pegol weekly for 26 weeks administered i.v. by continuous infusion plus radiotherapy during weeks 1-6
Receives: Drug: Olaptesed pegol; Radiation: Radiotherapy
Cohort 3: 600 mg Olaptesed pegol + RadiotherapyExperimentalolaptesed pegol weekly for 26 weeks administered i.v. by continuous infusion plus radiotherapy during weeks 1-6
Receives: Drug: Olaptesed pegol; Radiation: Radiotherapy
Expansion group, Arm A: 600 mg Olaptesed pegol + Radiotherapy + 10 mg/kg BevacizumabExperimentalolaptesed pegol weekly for 26 weeks administered i.v. by continuous infusion, bevacizumab every two weeks for 26 weeks plus radiotherapy during weeks 1-6, incompletely or not resected patients
Receives: Drug: Olaptesed pegol; Radiation: Radiotherapy; Drug: Bevacizumab
Expansion group, Arm B: 600 mg Olaptesed pegol + RadiotherapyExperimentalolaptesed pegol weekly for 26 weeks administered i.v. by continuous infusion plus radiotherapy during weeks 1-6, completely resected patients
Receives: Drug: Olaptesed pegol; Radiation: Radiotherapy
Expansion group, Arm C: 600 mg Olaptesed pegol + Radiotherapy + 200 mg PembrolizumabExperimentalolaptesed pegol weekly for 26 weeks administered i.v. by continuous infusion, pembrolizumab every three weeks for 26 weeks plus radiotherapy during weeks 1-6, incompletely resected patients
Receives: Drug: Olaptesed pegol; Radiation: Radiotherapy; Drug: Pembrolizumab
Expansion group, Arm D: 200 mg Olaptesed pegol + Radiotherapy + 10 mg/kg BevacizumabExperimentalolaptesed pegol i.v. by continuous infusion, bevacizumab every two weeks plus radiotherapy during weeks 1-6, until progression or intolerable toxicity (patients with disease progression may continue treatment with all assessments if deemed appropriate by the investigator), incompletely resected patients
Receives: Drug: Olaptesed pegol; Radiation: Radiotherapy; Drug: Bevacizumab
Expansion group, Arm E: 400 mg Olaptesed pegol + Radiotherapy + 10 mg/kg BevacizumabExperimentalolaptesed pegol i.v. by continuous infusion, bevacizumab every two weeks plus radiotherapy during weeks 1-6, until progression or intolerable toxicity (patients with disease progression may continue treatment with all assessments if deemed appropriate by the investigator), incompletely resected patients
Receives: Drug: Olaptesed pegol; Radiation: Radiotherapy; Drug: Bevacizumab
Expansion group, Arm F: 600 mg Olaptesed pegol + Radiotherapy + 10 mg/kgBevacizumabExperimentalolaptesed pegol i.v. by continuous infusion, bevacizumab every two weeks plus radiotherapy during weeks 1-6, until progression or intolerable toxicity (patients with disease progression may continue treatment with all assessments if deemed appropriate by the investigator), incompletely resected patients
Receives: Drug: Olaptesed pegol; Radiation: Radiotherapy; Drug: Bevacizumab
Expansion group, Arm G: 600 mg Olaptesed pegol + RadiotherapyExperimentalolaptesed pegol i.v. by continuous infusion, bevacizumab every two weeks plus radiotherapy during weeks 1-6, until progression or intolerable toxicity (patients with disease progression may continue treatment with all assessments if deemed appropriate by the investigator), incompletely resected patients
Receives: Drug: Olaptesed pegol; Radiation: Radiotherapy
Expansion group, Arm H: Standard of care - Temozolomide + RadiotherapyActive comparatororal treatment up to 35 weeks according to current SPC
Receives: Radiation: Radiotherapy; Drug: Temozolomide (TMZ)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety - Number of patients with treatment-related adverse events as assessed by CTCAE

    Number of patients with treatment-related adverse events as assessed by CTCAE

    Measured: through study completion, an average of 3 years

Secondary outcomes (10)

  1. Efficacy - progression free survival at 6 months (PFS-6)

    Progression free survival at 6 months (PFS-6) in %

    Measured: 6 months

  2. Efficacy - Median progression-free survival (mPFS)

    Median progression-free survival (mPFS) in months

    Measured: until end of treatment, an average 1 year

  3. Efficacy - Median overall survival (mOS)

    Median overall survival (mOS) in months

    Measured: through study completion, an average of 3 years

  4. Efficacy - Landmark overall survival at 18 months (OS18)

    Measured: 18 months

  5. Overall response rate (ORR)

    Measured: through study completion, an average of 3 years

  6. Plasma level of olaptesed pegol

    concentration of olaptesed pegol in plasma in µmol/L

    Measured: 9 weeks after treatment start

  7. Quality of Life (QoL) EORTC QLQ-C30 Module

    Quality of Life measures are recorded according to EORTC QLQ30 module, which is validated for cancer patients in general and measured as a unit of scale. This is a standard tool for assessing patient reported quality of Life along time during treatment.

    Measured: through study completion, an average of 3 years

  8. Quality of Life (QoL) EORTC QLQ BN-20 Module

    Quality of Life measures are recorded according to EORTC QLQ BN-20 module, which is validated for brain tumor patients and measured as a unit of scale. This is a standard tool for assessing patient reported quality of Life along time during treatment.

    Measured: through study completion, an average of 3 years

  9. Efficacy - Tumor vascularization as per vascular MRI

    Changes from baseline in tumor vascularization over time as %cerebral blood volume

    Measured: through study completion, an average of 3 years

  10. Neurologic functions as measured by the NANO scale

    Change from baseline in neurologic performance scores by Neurologic Assessment in Neuro-Oncology (NANO) scale as an objective and quantifiable metric of neurologic function evaluable during a routine office examination. The NANO Scale evaluates 9 major domains of neurologic function, with each domain being scored on a range from 0 to 2 or 3.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2019
  2. Study start12 Sep 2019
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
3+3 dose escalation (sequential) followed by a multiple-arm expansion group (parallel)
Masking
None (open label)
Enrolment
117 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04121455
Sponsor's protocol ID
SNOXA12C401
Other IDs
2024-510964-21-00, 2018-004064-62, 2018
Acronym
GLORIA
Status last verified
Jun 2025
First submitted
25 Sep 2019
Last updated
25 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Olaptesed pegol, Radiotherapy and Bevacizumab in people with Glioblastoma, run by TME Pharma AG at 6 sites in Germany.

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 52 inclusion and 107 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 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. 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?

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?

Safety - Number of patients with treatment-related adverse events as assessed by CTCAE (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04121455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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