What this study is
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.
What's being tested
- AZD0305
Intervention · DRUG
AZD0305 Investigational product
- Elranatamab
Intervention · DRUG
Module 2 Investigational product
- Pomalidomide
Intervention · DRUG
- Dexamethasone
Intervention · DRUG
Both Pomalidomide and Dexamethasone
Module 3 Standard of Care (background treatment)
Study details
- Official title
- 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
- Sponsor
- AstraZeneca
- Conditions
- Multiple Myeloma
- Enrolling
- 226 people
- Starts
- 2023-12-05
- Est. completion
- 2028-01-24
- Design
- Open-label, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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 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 uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and/or other administration
- 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 exhibiting clinical signs of central nervous system involvement of MM;
- 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.
- Participants with known severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification;
- Participants who have severe cardio vascular disease which is not adequately controlled.
- Participants who have a history of immunodeficiency disease.
- Participants with peripheral neuropathy ≥ Grade2.
- Primary refractory MM.
- The above is a summary of key criteria, other exclusion criteria details may apply
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (46)
44 openResearch Site
Duarte, California, United States
RecruitingResearch Site
Irvine, California, United States
RecruitingResearch Site
Atlanta, Georgia, United States
RecruitingResearch Site
Boston, Massachusetts, United States
RecruitingResearch Site
Ann Arbor, Michigan, United States
RecruitingResearch Site
New York, New York, United States
RecruitingResearch Site
Philadelphia, Pennsylvania, United States
RecruitingResearch Site
Fairfax, Virginia, United States
RecruitingResearch Site
St Louis, Missouri, United States
Withdrawn
37 sites outside the US
Research Site
Fitzroy, Australia
RecruitingResearch Site
Melbourne, Australia
RecruitingResearch Site
Nedlands, Australia
RecruitingResearch Site
Wollongong, Australia
Not yet recruitingResearch Site
Salvador, Brazil
Not yet recruitingResearch Site
São Paulo, Brazil
RecruitingResearch Site
São Paulo, Brazil
RecruitingResearch Site
Hamilton, Ontario, Canada
RecruitingResearch Site
Ottawa, Ontario, Canada
RecruitingResearch Site
Toronto, Ontario, Canada
Not yet recruitingResearch Site
Montreal, Quebec, Canada
RecruitingResearch Site
Nova Scotia, Canada
Not yet recruitingResearch Site
Beijing, China
RecruitingResearch Site
Changsha, China
RecruitingResearch Site
Guangzhou, China
RecruitingResearch Site
Shenyang, China
RecruitingResearch Site
Lille, France
RecruitingResearch Site
Nantes, France
RecruitingResearch Site
Essen, Germany
RecruitingResearch Site
Hamburg, Germany
RecruitingResearch Site
Heidelberg, Germany
Not yet recruitingResearch Site
Lübeck, Germany
RecruitingResearch Site
Nuremberg, Germany
RecruitingResearch Site
Tübingen, Germany
Not yet recruitingResearch Site
Würzburg, Germany
RecruitingResearch Site
Kashiwa, Japan
RecruitingResearch Site
Nagoya, Japan
RecruitingResearch Site
Yamagata, Japan
RecruitingResearch Site
Badalona, Spain
RecruitingResearch Site
Madrid, Spain
RecruitingResearch Site
Madrid, Spain
RecruitingResearch Site
Pamplona, Spain
RecruitingResearch Site
Salamanca, Spain
RecruitingResearch Site
Leeds, United Kingdom
Not yet recruitingResearch Site
Manchester, United Kingdom
Not yet recruitingResearch Site
Plymouth, United Kingdom
Not yet recruitingResearch Site
Freiburg im Breisgau, Germany
Withdrawn
Study team
Sponsor
AstraZeneca
Study ID D7230C00001
CONTACT
AstraZeneca Clinical Study Information Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.