Relapsed or Refractory Multiple Myeloma
Conditions
Brief summary
Occurrence of dose-limiting toxicities (Phase Ia dose escalation only)., Incidence and severity of AEs and SAEs.
Detailed description
Preliminary efficacy of AZD0305 according to IMWG 2016 response criteria as assessed byinvestigator, including response endpoints ORR, DoR, PFS, and OS., 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., The number and percentage of participants who develop Anti-Drug Antibody (ADA).
Interventions
DRUGAZD0305
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of dose-limiting toxicities (Phase Ia dose escalation only)., Incidence and severity of AEs and SAEs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary efficacy of AZD0305 according to IMWG 2016 response criteria as assessed byinvestigator, including response endpoints ORR, DoR, PFS, and OS., 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., The number and percentage of participants who develop Anti-Drug Antibody (ADA). | — |
Countries
France, Germany, Spain
Outcome results
None listed