AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma

Korábbi kezelés

• Participants who have previously received anti-GPRC5D or MMAE-containing treatment
• Participants with a known hypersensitivity toAZD0305 or any of the excipients of the productor to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior mono clonal antibody therapy
• Participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3months before the first dose of study intervention
• Participants with known history of severe or very severe COPD, or previous history of non-infectious ILD/pneumonitis that has required oral or IV steroids of supplemental oxygen, or where suspected suspected ILD/pneumonitis cannot be ruled out by imaging at screening.

Más betegség

• Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma(compliant with WHO criteria);
• 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 who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and/or other administration
• Participants who have severe cardio vascular disease which is not adequately controlled.
• Participants who have a history of immunodeficiency disease.

Egyéb

• Participants exhibiting clinical signs of central nervous system involvement of MM;
• Participants with known severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification;
• Participants with peripheral neuropathy ≥ Grade2.
• Primary refractory MM.
• The above is a summary of key criteria, other exclusion criteria details may apply

• 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 module specific inclusion criteria details may apply