AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics and efficacy of AZD0305 as monotherapy and in combination with other anticancer agents in participants with MM.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma (compliant with WHO criteria);
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;
Trial design
Treatments tested in this trial
- AZD0305
- Elranatamab
- Pomalidomide
- Dexamethasone
Treatment groups
226 Participants
are divided into 3 treatment groupsLocations
43Australia
Research SiteVIC3065, Fitzroy Australia
Research Site3000, Melbourne Australia
Research Site6009, Nedlands Australia
Research Site2500, Wollongong Australia
Sponsors and collaborators
AstraZeneca
Lead sponsor
Source ClinicalTrials.gov