Actively Recruiting
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Led by AstraZeneca · Updated on 2026-05-06
226
Participants Needed
40
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old or the legal age of consent
- Eastern Cooperative Oncology Group performance status of 2 or less in module 1, or 0 or 1 in modules 2 and 3
- Confirmed diagnosis of Multiple Myeloma according to International Myeloma Working Group criteria
- Measurable disease based on Serum M-Protein, Urine M-protein, or Serum immunoglobulin free light chains
- Adequate organ and bone marrow function as specified for each study module
- At least 3 prior lines of treatment for module 1, or 1 to 3 prior lines for modules 2 and 3 with additional module-specific requirements
You will not qualify if you...
- Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma
- Signs of central nervous system involvement of Multiple Myeloma
- Known chronic obstructive pulmonary disease or history of interstitial lung disease/pneumonitis
- Moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma
- Severe uncontrolled cardiovascular disease
- History of immunodeficiency disease
- Peripheral neuropathy grade 2 or higher
- Primary refractory Multiple Myeloma
- Previous treatment with anti-GPRC5D or MMAE-containing therapies
- Previous allogenic stem cell transplant or autologous transplant within 3 months prior to study
- History of other malignancies within 3 years except some exceptions
- History of active JC virus infection causing progressive multifocal leukoencephalopathy
- Known hypersensitivity to AZD0305 or related drugs or severe hypersensitivity to prior monoclonal antibody treatment
- Uncontrolled severe illness including active infections requiring antibiotics or other treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
Research Site
Duarte, California, United States, 91010
Actively Recruiting
2
Research Site
Irvine, California, United States, 92618
Actively Recruiting
3
Research Site
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Research Site
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
Research Site
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Research Site
New York, New York, United States, 10065
Actively Recruiting
8
Research Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Research Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
10
Research Site
Fitzroy, Australia, VIC3065
Not Yet Recruiting
11
Research Site
Melbourne, Australia, 3000
Actively Recruiting
12
Research Site
Nedlands, Australia, 6009
Actively Recruiting
13
Research Site
Wollongong, Australia, 2500
Not Yet Recruiting
14
Research Site
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
15
Research Site
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
16
Research Site
Toronto, Ontario, Canada, M5G 2M9
Not Yet Recruiting
17
Research Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
18
Research Site
Nova Scotia, Canada, B3H 1V7
Not Yet Recruiting
19
Research Site
Beijing, China, 100044
Actively Recruiting
20
Research Site
Changsha, China, 410013
Actively Recruiting
21
Research Site
Guangzhou, China, 510060
Actively Recruiting
22
Research Site
Shenyang, China, 110134
Actively Recruiting
23
Research Site
Lille, France, 59037
Actively Recruiting
24
Research Site
Nantes, France, 44000
Actively Recruiting
25
Research Site
Essen, Germany, 45147
Actively Recruiting
26
Research Site
Freiburg im Breisgau, Germany, 79106
Withdrawn
27
Research Site
Hamburg, Germany, 20246
Actively Recruiting
28
Research Site
Heidelberg, Germany, 69120
Not Yet Recruiting
29
Research Site
Lübeck, Germany, 23538
Actively Recruiting
30
Research Site
Nuremberg, Germany, 90419
Actively Recruiting
31
Research Site
Tübingen, Germany, 72076
Not Yet Recruiting
32
Research Site
Würzburg, Germany, 97080
Actively Recruiting
33
Research Site
Kashiwa, Japan, 277-8577
Actively Recruiting
34
Research Site
Nagoya, Japan, 467-8602
Actively Recruiting
35
Research Site
Yamagata, Japan, 990-9585
Actively Recruiting
36
Research Site
Badalona, Spain, 8916
Not Yet Recruiting
37
Research Site
Madrid, Spain, 28027
Actively Recruiting
38
Research Site
Madrid, Spain, 28041
Actively Recruiting
39
Research Site
Pamplona, Spain, 31005
Actively Recruiting
40
Research Site
Salamanca, Spain, 37007
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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