A trial to learn if AZD0305 alone and in combination with other cancer treatments is safe and works in adults with relapsed or refractory multiple myeloma
- Conditions
- Relapsed or Refractory Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-508590-89-00
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
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., Documentation of Multiple Myeloma (MM) as defined by International Myeloma WorkingGroup (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that MultipleMyeloma diagnosis is confirmed in accordance with the IMWG Diagnostic Criteria., Participants must have one or more of the following measurable disease criteria: Serum M-protein level = 0.5 g/dL., Participants must have one or more of the following measurable disease criteria: (b) Urine M-protein level = 200 mg/24h., Participants must have one or more of the following measurable disease criteria: Serum immunoglobulin free light chain = 10 mg/dL and abnormal serum immunoglobulinkappa lambda free light chain ratio., Adequate organ and bone marrow function assessment at screening according to thehematological, hepatic, and renal parameters listed in the CSP., Participants must have received at least 3 prior lines of treatment which include aproteasome inhibitor (e.g., bortezomib), an immunomodulator (e.g., lenalidomide), and ananti-CD38 antibody (e.g., daratumumab).
Amyloidosis, plasma cell leukemia (compliant with WHO criteria)., Participants who have previously received allogenic stem cell transplant, or participant hasreceived autologous stem cell transplant within 3 months before the first dose of studyintervention., Participants exhibiting clinical signs of central nervous system involvement of MM., Participants with known COPD, or previous history of ILD., Participants with known moderate or severe persistent asthma within the past 5 years, oruncontrolled 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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 RRMM.;Secondary Objective: To estimate the preliminary efficacy of AZD0305 as monotherapy and in combination withother anticancer agents in participants with RRMM., To evaluate the PK characteristics of AZD0305 as monotherapy and in combination withother anticancer agents in participants with RRMM., To assess the immunogenicity of AZD0305 as monotherapy and in combination with otheranticancer agents in participants with RRMM.;Primary end point(s): Occurrence of dose-limiting toxicities (Phase Ia dose escalation only)., Incidence and severity of AEs and SAEs.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Preliminary efficacy of AZD0305 according to IMWG 2016 response criteria as assessed byinvestigator, including response endpoints ORR, DoR, PFS, and OS.;Secondary end point(s):PK parameters of AZD0305 (total ADC), total antibody (conjugated and unconjugated) andMMAE, including but not limited to AUC, Cmax, tmax, clearance, and half-life, as data allow.;Secondary end point(s):The number and percentage of participants who develop Anti-Drug Antibody (ADA).