A Trial of KB004 in Patients With Glioblastoma
Palabras clave
Abstracto
fechas
Verificado por última vez: | 02/29/2020 |
Primero enviado: | 09/25/2017 |
Inscripción estimada enviada: | 12/10/2017 |
Publicado por primera vez: | 12/14/2017 |
Última actualización enviada: | 03/01/2020 |
Última actualización publicada: | 03/03/2020 |
Fecha de inicio real del estudio: | 12/04/2017 |
Fecha estimada de finalización primaria: | 10/21/2020 |
Fecha estimada de finalización del estudio: | 04/21/2021 |
Condición o enfermedad
Intervención / tratamiento
Drug: KB004 dose escalation
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Experimental: KB004 dose escalation Patients will be entered at each KB004 dose level sequentially until 3-6 patients are evaluable for safety. Three sequential cohorts are planned in this study (3.5mg/kg, 5.25 mg/kg, 7.9 mg/kg) Additional dose levels may be explored based on the emerging data in the study. | Drug: KB004 dose escalation KB004 is a recombinant, non-fucosylated, IgG1κ (human f-allotype) monoclonal antibody targeting the extracellular ligand binding domain of the EphA3 (ephrin receptor) tyrosine kinase |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - Adults (greater than or equal to 18 years of age) with histologically proven glioblastoma - Evidence of progressive glioblastoma (if within 3 months of radiotherapy, then progression outside of radiotherapy field is required) - Measurable disease by RANO (Response Assessment in Neuro-Oncology Criteria) - ECOG (Eastern Cooperative Oncology Group score) 0 to 1 - Expected survival more than 3 months - Steroid dose less than 2.5 mg per day dexamethasone equivalents and stable or reducing for 1 week prior to day 1 - Archived (formalin fixed paraffin embedded) tissue or frozen tumour tissue or consent to obtain a fresh tumour biopsy at enrolment is required. - Adequate organ function. Out of range values that are not clinically significant will be permitted, except for the following laboratory parameters which must be within the ranges specified - Neutrophils greater than or equal to 1.5 x 109 per L - Platelets greater than or equal to 100 x 109 per L - International Normalised Ratio less than or equal to 1.4 - Serum Aspartate aminotransferase and Alanine aminotransferase less than or equal to 2.5 x ULN (upper limit of normal) - Serum bilirubin less than or equal to 1.5 x ULN (upper limit of normal) Exclusion Criteria: - Evidence of infratentorial, extracranial or leptomeningeal disease - More than one prior systemic therapy for progressive disease or prior Steriotactic radiosurgery (SRS) to sites of GB (glioblastoma). - Prior treatment with bevacizumab or gliadel wafers - Evidence of current or prior intracranial hemorrhage - Need for anti-platelet or anti-coagulant drugs - Use of anti-cancer therapy including craniotomy, chemotherapy, immunotherapy, radiotherapy, or any investigational therapy within 28 days prior to Study Day 1 - History of major immunologic reaction to any immunoglobulin G containing agent - Medical conditions which place the subject at an unacceptably high risk - Subject is pregnant, lactating or unwilling or unable to use adequate contraception |
Salir
Medidas de resultado primarias
1. Number of Participants With KB004 Treatment-Related Adverse Events as Assessed using CTCAE v4.0. To determine the maximum tolerated dose (MTD). [0-24 months]
Medidas de resultado secundarias
1. Biodistribution of 89Zr-KB004 [0-24 months]
2. Response rates following KB004 infusion [0-24 months]
3. Plasma concentration versus time (Serum half life) of 89Zr-KB004 [0-43 days]
4. Cmax of 89Zr-KB004 [0-43 days]
Otras medidas de resultado
1. clinical outcomes via RANO criteria (Response Assessment in Neuro-Oncology Criteria) [0-24 Months]
2. Biodistribution via PET (Positron-emission tomography) [0-43 days]