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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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MechanismCXCR4 antagonists |
Active Org.- |
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Active Indication- |
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Drug Highest PhasePending |
First Approval Ctry. / Loc.- |
First Approval Date- |
A Pivotal Phase 3 Clinical Trial to Assess the Diagnostic Performance and Safety of [68Ga]Ga-PentixaFor ([68Ga]Ga-PTF), a Positron Emission Tomography (PET) Imaging Agent, Versus [18F]FDG PET/CT Imaging, for Staging of Patients With Confirmed Marginal Zone Lymphoma Exemplary for CXCR4-positive Malignant Lymphomas: a Prospective, International, Multi-center, Comparative, Randomized, Cross-over, Open-label Lymphoma Diagnostic Trial
This will be a pivotal prospective prospective, international, multi-center, comparative, randomized, cross-over, open-label lymphoma diagnostic trial to assess the diagnostic performance and safety of the positron emission tomography (PET) imaging agent [68Ga]Ga-PTF) , versus [18F]FDG PET/CT imaging, for staging of patients with confirmed marginal zone lymphoma exemplary for CXCR4-positive malignant lymphomas.
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.
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.
A Prospective, International, Multi-centre, Open-label, Single-arm Phase II Study Investigating the Predictive Value of [68Ga]Ga PentixaFor PET Imaging in Primary and Isolated Secondary CNS Lymphoma Patients
This will be an open, single-arm, international, multicentre, phase II imaging study to assess the predictive value of [68Ga]Ga PentixaFor PET imaging in primary and isolated secondary central nervous system lymphoma (CNSL) patients scheduled to undergo induction chemotherapy.
100 Clinical Results associated with PentixaPharm GmbH
0 Patents (Medical) associated with PentixaPharm GmbH
100 Deals associated with PentixaPharm GmbH
100 Translational Medicine associated with PentixaPharm GmbH