CNS LymphomaPhase 1/2NCT06132737
[90Y]Y-PTT Endoradiotherapy in CNS Lymphoma Patients
A Phase 1/2 study testing [90Y]Y-PentixaTher in people with CNS Lymphoma, run by Pentixapharm AG at 2 sites in Germany.
Trial summary
This will be an open-label, single-arm, national phase 1/2 therapeutic study to evaluate the safety, tolerability, and preliminary efficacy of [90Y]Y-PentixaTher ([90Y]Y-PTT) for the treatment of recurrent or refractory primary or isolated secondary central nervous system (CNS) lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- CNS Lymphoma
- What is being tested?
- [90Y]Y-PentixaTher
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesGermany
- Study dates
- 7 Nov 2023to 26 Mar 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are eligible to be included in the study only if all of the following criteria apply and are maintained at Day -2 to Day 0 (before IMP infusion):
- Signed informed consent, by the patient or an authorized legal guardian in case the patient is temporarily not competent due to his or her disease, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Patients of either gender aged > 18 years.
- Body weight < 180 kg.
- At least one measurable lymphoma manifestation in the CNS, either contrast-enhanced lesion in the brain parenchyma or measurable meningeal lesion.
- Histologically, cytologically or radiologically confirmed relapsed/refractory primary central nervous system lymphoma (PCNSL) or relapsed/refractory secondary central nervous system lymphoma (SCNSL). Initial histologic confirmation at first diagnosis is mandatory. No peripheral lymphoma evidence is allowed.
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- Recurrent or refractory CNSL
- For recurrent disease, comprising new lesions or recurrent CNSL after a complete response (CR) at that site, there are no maximum number of recurrences.
- Refractory CNSL comprises patients with non-responding CNSL (no objective response rate (ORR), no progressive disease (PD)) to frontline therapy, or progressive disease after an initial, partial response (PR).
- Stored stem cells with at least ≥ 2 x 106 CD34+ cells/kg of body weight.
- If sexually active female patient of childbearing potential: patient agrees to take adequate contraceptive measures during study participation and agrees to continue use of this method for the duration of the study and for six months after the last dose.
- Female patient without childbearing potential: documented history (e.g., tubal ligation or hysterectomy) or is post-menopausal.
- For male patient whose partner is of child-bearing potential: patient is willing to ensure that he and his partner use effective contraception during the study and for six months after 90Y-PTT treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Confirmed presence of CXCR4 on technically evaluable tumor lesions documented by a visually CXCR4-positive [68Ga]Ga-PentixaFor positron emission tomography (PET) scan within two months prior to enrolment in the study or during Screening.
- Blood test results as follows:
- Absolute neutrophil count: > 1.0 x 109/L
- Hemoglobin: ≥ 8 g/dL
- Platelets: ≥ 75 x 109/L
- Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP): ≤ 3 x ULN (upper limit of normal)
- Serum creatinine: ≤ 2 x ULN and Cockcroft Gault calculated glomerular filtration rate (GFR) ≥ 50 mL/min
- Bilirubin: ≤ 3 x ULN
Who cannot join
- Patients are excluded from the study if any of the following criteria apply during screening or Day -2 to Day 0 (before IMP infusion):
- Known or suspected hypersensitivity to study product(s) or related products.
- Contraindication for contrast-enhanced magnetic resonance imaging (MRI) as set out in the relevant institutional guidelines (e.g., pacemaker, defibrillator, aneurysm clip, metal in the body, renal insufficiency, severe claustrophobia etc.) or contraindication for the use of gadolinium contrast for MRI.
- Previous participation in this study. Participation is defined as signed informed consent.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). A pregnancy test will be performed at the start of the study for all female patients of childbearing potential (i.e., not surgically sterile or two years postmenopausal).
- Male of reproductive age who or whose partner(s) is not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
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- Participation in any clinical study of an approved or non-approved investigational medicinal product (IMP) within the last 30 days (or ≤ 5 terminal elimination half-lives of previous IMP, whichever is longer) before screening.
- Any disorder (e.g., active infection, unstable angina pectoris, cardiac arrhythmia (excluding atrial fibrillation and atrial flutter, uncontrolled congestive heart failure), poorly controlled hypertension, poorly controlled diabetes mellitus [HbA1c ≥ 9%], etc.) or laboratory findings, except for conditions associated with CNS lymphoma, which in the investigator's opinion might jeopardize patient's safety or compliance with the protocol.
- Presence of active infection, or history of serious infection six weeks prior to IMP administration. Patients with uncontrolled human immunodeficiency virus (HIV) infection as well as acute or chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are excluded (Note: Patients on antiretroviral therapy (ART) with controlled HIV infection (defined as sufficient ART compliance, non-measurable HIV and CD4+ T helper cells > 200/Micro Liter) may be enrolled, if considered eligible for study treatment by the investigator.).
- SCNSL with systemic involvement.
- Chronic use (> 21 days) of immunosuppressive drugs, e.g., steroids for systemic autoimmune disease, due to previous organ transplantation, or other clinically evident form of immunodeficiency. Patients receiving only acute treatment (less than 21 days) with corticosteroids can be included.
- Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude without designated legal representative.
- Brain radiation therapy ≤ 180 days before IMP infusion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 1 recruiting
- Recruiting
University Hospital Essen
Essen
Bastian von Tresckow, Prof. Dr. med.
- Withdrawn
University Hospital Rechts der Isar
Munich, Bavaria, 81675
About this study
Official title: An Open-label Dose Escalation Study to Evaluate Safety, Tolerability, Biodistribution and Efficacy of [90Y]Y-PentixaTher for the Therapy of Recurrent or Refractory Primary or Isolated Secondary Central Nervous System Lymphoma.
This will be an open-label, single-arm, national phase 1/2 therapeutic study to evaluate the safety, tolerability, and preliminary efficacy of [90Y]Y-PentixaTher ([90Y]Y-PTT) for the treatment of recurrent or refractory primary or isolated secondary central nervous system (CNS) lymphoma.
The study will be performed in three cohorts with different dose levels according to the best-of-5 dose escalation design. A safety review committee (SRC) will evaluate dose-limiting toxicities and decide about escalation and de-escalation.
Read more
Eligible patients will receive one cycle of [90Y]Y-PTT, which will be administered intravenously. There will be no comparator in this study.
Safety, biodistribution, dosimetry and efficacy will be evaluated during the core study phase (Visit 1 until Visit 5). Thereafter three follow-up (FU) visits will take place, at three-months intervals to evaluate the extent of disease.
- Conditions
- CNS Lymphoma
- Being tested
- [90Y]Y-PentixaTher
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[90Y]Y-PentixaTherDrug
Also called [90Y]Y-PTT
[90Y]Y-PTT i.v. injection
| Study group | Role | What they receive |
|---|---|---|
| [90Y]Y-PTT | Experimental | The study will be performed in three cohorts with different dose levels. Eligible patients will receive one cycle of 90Y-PTT, which will be administered intravenously. Receives: Drug: [90Y]Y-PentixaTher |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and relationship of (S)AEs (graded in severity according to NCI CTCAE version 5.0)
Incidence, severity and relationship of (/serious) adverse events (S)AEs will be analyzed by descriptive statistical methods. The analyses will be based on the safety analysis set (SAF).
AEs as well as SAEs will be tabulated. Verbatim terms will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and tabulations will occur by System Organ Class and Preferred Term. Severity will be graded and tabulated according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Treatment-emergent AEs will be the focus of the analyses. AEs and SAEs assessed as causality related to IMP by the investigator, and AEs leading to death will be tabulated separately.
Measured: From screening until including the last follow-up visit. SAEs occuring after the end of the study should only be reported to Pentixapharm if the Investigator considers there is a causal relationship with the study drug.
Secondary outcomes (12)
Maximal uptake (%) for tumor lesion
The lesion activity values will be determined manually. Two volume of interests (VOIs) are drawn around a slightly enlarged organ/lesion contour, based on the computed tomography (CT) and a sphere centered around the maximal activity.
Measured: 1 ± 0.5 hours post infusion (p.i.).; 5 ± 1 hours p.i.; 22 ± 4 hours p.i.; 30 ± 4 hours p.i.
Maximal uptake (%) in discernible organs
The organ activity values will be determined manually. Two volume of interests (VOIs) are drawn around a slightly enlarged organ/lesion contour, based on the CT and a sphere centered around the maximal activity.
Measured: 1 ± 0.5 hours post infusion (p.i.); 5 ± 1 hours p.i.; 22 ± 4 hours p.i.; 30 ± 4 hours p.i.
TAC in discernible thoracic and abdominal organs, target lesion and blood
The organ/lesion activity values will be determined manually. Two volume of interests (VOIs) are drawn around a slightly enlarged organ/lesion contour, based on the CT and a sphere centered around the maximal activity.
For both evaluations the total activity will be noted and scaled to the injected activity.
The Time activity curves (TAC) will be calculated. The blood samples will be measured in a calibrated well counter. Applying the calibration factor, the counts will be converted to activity of the blood samples.
Measured: Discernible thoracic /abdominal organs /target lesion: 1 ± 0.5 hours post infusion (p.i.).; 5 ± 1 hours p.i.; 22 ± 4 hours p.i.; 30 ± 4 hours p.i. For Blood: 5 ± 2 minutes, 30 ± 5 minutes, 1 hour ± 10 minutes, 5 ± 1 hours, 22 ± 4 hours, 48 ± 6 hours p.i.
AUC of 90Y-PTT in discernible thoracic and abdominal organs, target lesion and blood
The organ/lesion activity values will be determined manually. Two volume of interests (VOIs) are drawn around a slightly enlarged organ/lesion contour, based on the CT and a sphere centered around the maximal activity.
For both evaluations the total activity will be noted and scaled to the injected activity.
The time activity curves (TAC) will be calculated. The blood samples will be measured in a calibrated well counter. Applying the calibration factor, the counts will be converted to activity of the blood samples.
The area under the curve (AUC) will be calculated.
Measured: Discernible thoracic /abdominal organs /target lesion: 1 ± 0.5 hours post infusion (p.i.).; 5 ± 1 hours p.i.; 22 ± 4 hours p.i.; 30 ± 4 hours p.i. For blood: 5 ± 2 minutes, 30 ± 5 minutes, 1 hour ± 10 minutes, 5 ± 1 hours, 22 ± 4 hours, 48 ± 6 hours p.i.
AUC of 90Y-PTT in urine
The activity concentrations of the collected urine will be measured in a well counter.
The area under the curve (AUC) will be calculated.
Measured: 0 - 5 hours (before 2nd PET scan); 5 - 22 hours (before 3rd PET scan); 22 - 48 hours
Organ receiving the highest absorbed dose
The organ/lesion activity values will be determined manually. Two volume of interests (VOIs) are drawn around a slightly enlarged organ/lesion contour, based on the computed tomography (CT) and a sphere centered around the maximal activity.
Measured: 1 ± 0.5 hours post infusion (p.i).; 5 ± 1 hours p.i.; 22 ± 4 hours p.i.; 30 ± 4 hours p.i.
Cumulative absorbed organ/lesion doses (Gy)
The organ/lesion activity values will be determined manually. Two volume of interests (VOIs) are drawn around a slightly enlarged organ/lesion contour, based on the CT and a sphere centered around the maximal activity.
Measured: 1 ± 0.5 hours post infusion (p.i).; 5 ± 1 hours p.i.; 22 ± 4 hours p.i.; 30 ± 4 hours p.i.
ORR at one month and three months
Proportion of patients who have partial response or complete response after treatment during study duration according to (International Primary Central Nervous System Lymphoma Collaborative Group) IPCG response criteria. This is also called the objective response rate (ORR).
Measured: Month 1 (Visit 4) and Month 3 (Visit 5)
PFS at one month and three months
Proportion of patients whose status results in death or progressive disease or disease relapse after achieving complete response according to IPCG response criteria. This is also called progression-free survival (PFS).
Measured: Month 1 (Visit 4) and Month 3 (Visit 5) post infusion
Rate of CR and PR at one month and three months
Proportion of patients with complete response (CR) and partial response (PR) according to IPCG response criteria.
Measured: Month 1 (Visit 4) and Month 3 (Visit 5) post infusion
PFS at 12 month (including a nine-month FU according to the local investigator's discretion)
Progression free survival (PFS) of patients according to IPCG response criteria.
Measured: 6 months post infusion (p.i.); 9 months p.i.; 12 months p.i.;
OS at 12 month (including a nine-month FU according to the local investigator's discretion)
Overall survival (OS) at 6 months, 9 months and 12 months after infusion is assessed.
Measured: 6 months post infusion (p.i.); 9 months p.i.; 12 months p.i.;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start7 Nov 2023
- Primary completion23 Sep 2027 (estimated)
- Study completion26 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS LymphomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pentixapharm AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bastian von Tresckow, Prof. Dr. med., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132737
- Sponsor's protocol ID
- PTT101
- Status last verified
- May 2026
- First submitted
- 6 Nov 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Dose Escalation Study to Evaluate Safety, Tolerability, Biodistribution and Efficacy of [90Y]Y-PentixaTher for the Therapy of Recurrent or Refractory Primary or Isolated Secondary Central Nervous System Lymphoma.
- ClinicalTrials.gov ID
- NCT06132737
- Acronym / sponsor ID
- PTT101
- Conditions
- CNS Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Pentixapharm AGIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 23 Sep 2027 (estimated)
- Study completion
- 26 Mar 2028 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be an open-label, single-arm, national phase 1/2 therapeutic study to evaluate the safety, tolerability, and preliminary efficacy of [90Y]Y-PentixaTher ([90Y]Y-PTT) for the treatment of recurrent or refractory primary or isolated secondary central nervous system (CNS) lymphoma.
The study will be performed in three cohorts with different dose levels according to the best-of-5 dose escalation design. A safety review committee (SRC) will evaluate dose-limiting toxicities and decide about escalation and de-escalation.
Eligible patients will receive one cycle of [90Y]Y-PTT, which will be administered intravenously. There will be no comparator in this study.
Safety, biodistribution, dosimetry and efficacy will be evaluated during the core study phase (Visit 1 until Visit 5). Thereafter three follow-up (FU) visits will take place, at three-months intervals to evaluate the extent of disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [90Y]Y-PTT | Experimental | Drug: [90Y]Y-PentixaTherThe study will be performed in three cohorts with different dose levels. Eligible patients will receive one cycle of 90Y-PTT, which will be administered intravenously. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients are eligible to be included in the study only if all of the following criteria apply and are maintained at Day -2 to Day 0 (before IMP infusion):
- Signed informed consent, by the patient or an authorized legal guardian in case the patient is temporarily not competent due to his or her disease, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Patients of either gender aged > 18 years.
- Body weight < 180 kg.
- At least one measurable lymphoma manifestation in the CNS, either contrast-enhanced lesion in the brain parenchyma or measurable meningeal lesion.
Key exclusion criteria (13 listed)
- Patients are excluded from the study if any of the following criteria apply during screening or Day -2 to Day 0 (before IMP infusion):
- Known or suspected hypersensitivity to study product(s) or related products.
- Contraindication for contrast-enhanced magnetic resonance imaging (MRI) as set out in the relevant institutional guidelines (e.g., pacemaker, defibrillator, aneurysm clip, metal in the body, renal insufficiency, severe claustrophobia etc.) or contraindication for the use of gadolinium contrast for MRI.
- Previous participation in this study. Participation is defined as signed informed consent.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). A pregnancy test will be performed at the start of the study for all female patients of childbearing potential (i.e., not surgically sterile or two years postmenopausal).
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 |
|---|---|---|
| [90Y]Y-PentixaTherAlso: [90Y]Y-PTT[90Y]Y-PTT i.v. injection | Drug | [90Y]Y-PTT |
Primary outcome
Incidence, severity and relationship of (S)AEs (graded in severity according to NCI CTCAE version 5.0)
Time frame: From screening until including the last follow-up visit. SAEs occuring after the end of the study should only be reported to Pentixapharm if the Investigator considers there is a causal relationship with the study drug.
Incidence, severity and relationship of (/serious) adverse events (S)AEs will be analyzed by descriptive statistical methods. The analyses will be based on the safety analysis set (SAF). AEs as well as SAEs will be tabulated. Verbatim terms will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and tabulations will occur by System Organ Class and Preferred Term. Severity will be graded and tabulated according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Treatment-emergent AEs will be the focus of the analyses. AEs and SAEs assessed as causality related to IMP by the investigator, and AEs leading to death will be tabulated separately.
12 secondary outcomes
Maximal uptake (%) for tumor lesion
Time frame: 1 ± 0.5 hours post infusion (p.i.).; 5 ± 1 hours p.i.; 22 ± 4 hours p.i.; 30 ± 4 hours p.i.
Maximal uptake (%) in discernible organs
Time frame: 1 ± 0.5 hours post infusion (p.i.); 5 ± 1 hours p.i.; 22 ± 4 hours p.i.; 30 ± 4 hours p.i.
TAC in discernible thoracic and abdominal organs, target lesion and blood
Time frame: Discernible thoracic /abdominal organs /target lesion: 1 ± 0.5 hours post infusion (p.i.).; 5 ± 1 hours p.i.; 22 ± 4 hours p.i.; 30 ± 4 hours p.i. For Blood: 5 ± 2 minutes, 30 ± 5 minutes, 1 hour ± 10 minutes, 5 ± 1 hours, 22 ± 4 hours, 48 ± 6 hours p.i.
AUC of 90Y-PTT in discernible thoracic and abdominal organs, target lesion and blood
Time frame: Discernible thoracic /abdominal organs /target lesion: 1 ± 0.5 hours post infusion (p.i.).; 5 ± 1 hours p.i.; 22 ± 4 hours p.i.; 30 ± 4 hours p.i. For blood: 5 ± 2 minutes, 30 ± 5 minutes, 1 hour ± 10 minutes, 5 ± 1 hours, 22 ± 4 hours, 48 ± 6 hours p.i.
AUC of 90Y-PTT in urine
Time frame: 0 - 5 hours (before 2nd PET scan); 5 - 22 hours (before 3rd PET scan); 22 - 48 hours
Organ receiving the highest absorbed dose
Time frame: 1 ± 0.5 hours post infusion (p.i).; 5 ± 1 hours p.i.; 22 ± 4 hours p.i.; 30 ± 4 hours p.i.
Cumulative absorbed organ/lesion doses (Gy)
Time frame: 1 ± 0.5 hours post infusion (p.i).; 5 ± 1 hours p.i.; 22 ± 4 hours p.i.; 30 ± 4 hours p.i.
ORR at one month and three months
Time frame: Month 1 (Visit 4) and Month 3 (Visit 5)
PFS at one month and three months
Time frame: Month 1 (Visit 4) and Month 3 (Visit 5) post infusion
Rate of CR and PR at one month and three months
Time frame: Month 1 (Visit 4) and Month 3 (Visit 5) post infusion
PFS at 12 month (including a nine-month FU according to the local investigator's discretion)
Time frame: 6 months post infusion (p.i.); 9 months p.i.; 12 months p.i.;
OS at 12 month (including a nine-month FU according to the local investigator's discretion)
Time frame: 6 months post infusion (p.i.); 9 months p.i.; 12 months p.i.;
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 5 Jun 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.
Bastian von Tresckow, Prof. Dr. med. principal investigator
University Hospital, Essen
2 sites 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 [90Y]Y-PentixaTher in people with CNS Lymphoma, run by Pentixapharm AG at 2 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 22 inclusion and 13 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 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Simone Pickel (+49-172-426-9635, PTT101@pentixapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity and relationship of (S)AEs (graded in severity according to NCI CTCAE version 5.0) (time frame: From screening until including the last follow-up visit. SAEs occuring after the end of the study should only be reported to Pentixapharm if the Investigator considers there is a causal relationship with the study drug.). 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 5 Jun 2026.