A Modular Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants with Multiple Myeloma
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase I-II
PATOLOGÍA
Mieloma Múltiple y otras gammapatías
CENTRO INVESTIGADOR
H.U. 12 de Octubre
INVESTIGADOR PRINCIPAL
Joaquin Martinez
FECHA DE APERTURA
Mayo, 2024
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
Eastern Cooperative Oncology Group performance status of 2 in module 1, or 0 or 1 in modules 2 and 3
Documentation of Multiple Myeloma (MM) as defined by International Myeloma Working Group (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that Multiple Myeloma diagnosis is confirmed in accordance with the IMWG Diagnostic Criteria
Participants must have one or more measurable disease criteria for Serum M-Protein, Urine M-protein, and Serum immunoglobulin free light chains as specified in the relevant module of the CSP;
Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP as relevant to each module
Participants must have received at least 3 prior lines of treatment in module 1. In modules 2 and 3, participants must meet the phase-specific requirements for the number of prior lines of therapy.
The above is a summary of key criteria, other inclusion criteria details may apply
Eastern Cooperative Oncology Group performance status of 2 in module 1, or 0 or 1 in modules 2 and 3
Documentation of Multiple Myeloma (MM) as defined by International Myeloma Working Group (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that Multiple Myeloma diagnosis is confirmed in accordance with the IMWG Diagnostic Criteria
Participants must have one or more measurable disease criteria for Serum M-Protein, Urine M-protein, and Serum immunoglobulin free light chains as specified in the relevant module of the CSP;
Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP as relevant to each module
Participants must have received at least 3 prior lines of treatment in module 1. In modules 2 and 3, participants must meet the phase-specific requirements for the number of prior lines of therapy.
The above is a summary of key criteria, other inclusion criteria details may apply
CRITERIOS DE EXCLUSIÓN
Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma (compliant with WHO criteria);
Participants who have previously received anti-GPRC5D or MMAE-containing treatment.
Participants with a history of prior malignancy other than MM within 3 years prior to first dose of study intervention. some exceptions apply
Participants with previous history of active John Cunningham virus infection resulting in PML
Participants with a known hypersensitivity to AZD0305 or any of the excipients of the product or to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior monocloncal antibody therapy
Participants who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and/or other administration
The above is a summary of key criteria, other exclusion criteria details may apply
Participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3 months before the first dose of study intervention.
Participants exhibiting clinical signs of central nervous system involvement of MM;
Participants with known COPD, or previous history of ILD/pneumonitis
Participants with known moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification;
Participants who have severe cardiovascular disease which is not adequately controlled.
Participants who have a history of immunodeficiency disease.
Participants with peripheral neuropathy Grade 2.
Primary refractory MM.
Participants who have previously received anti-GPRC5D or MMAE-containing treatment.
Participants with a history of prior malignancy other than MM within 3 years prior to first dose of study intervention. some exceptions apply
Participants with previous history of active John Cunningham virus infection resulting in PML
Participants with a known hypersensitivity to AZD0305 or any of the excipients of the product or to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior monocloncal antibody therapy
Participants who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and/or other administration
The above is a summary of key criteria, other exclusion criteria details may apply
Participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3 months before the first dose of study intervention.
Participants exhibiting clinical signs of central nervous system involvement of MM;
Participants with known COPD, or previous history of ILD/pneumonitis
Participants with known moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification;
Participants who have severe cardiovascular disease which is not adequately controlled.
Participants who have a history of immunodeficiency disease.
Participants with peripheral neuropathy Grade 2.
Primary refractory MM.
DESCRIPCIÓN
To assess the safety and tolerability and determine the Recommended Phase 2 Dose (RP2D) of AZD0305 as monotherapy and in combination with other anticancer agents in participants with MM. This is the core primary objective of the study, module specific primary objectives are available within the CSP
PALABRAS CLAVE
multiple myeloma, myeloma
