Trial Title:
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma
NCT ID:
NCT06106945
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
GPRC5D
ADC
AZD0305
Relapsed Refractory Multiple Myeloma
RRMM
MMAE
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
This protocol has a modular design, with the potential for future treatment arms, study
parts, or modules to be added via protocol amendments. Module 1 will include Phase Ia
(Dose escalation), and Phase Ib (Dose expansion/optimization).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AZD0305
Description:
AZD0305
Arm group label:
AZD0305 monotherapy
Summary:
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 preliminary efficacy of AZD0305 in participants with RRMM.
Detailed description:
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 preliminary efficacy of AZD0305 in participants with RRMM. This
study will follow a modular protocol design evaluating AZD0305 as monotherapy and in
combination with other anticancer agents.
The study includes dose escalation and dose expansion phases. This study will enroll
subjects with RRMM who received at least 3 prior lines of treatment including at least
one proteasome inhibitor (PI), one immunomodulator (IMiD), and an anti-CD38 antibody.
Subjects will be administered AZD0305 intravenously.
Criteria for eligibility:
Criteria:
Principal Inclusion Criteria:
- 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 (ECOG) performance status of ≤ 2.
- 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 of the following measurable disease criteria:
1. Serum M-protein level ≥ 0.5 g/dL.
2. Urine M-protein level ≥ 200 mg/24h.
3. Serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum
immunoglobulin kappa lambda free light chain ratio.
- Adequate organ and bone marrow function assessment at screening according to the
hematological, hepatic, and renal parameters listed in the CSP.
- Participants must have received at least 3 prior lines of treatment which include a
proteasome inhibitor (e.g., bortezomib), an immunomodulator (e.g., lenalidomide),
and an anti-CD38 antibody (e.g., daratumumab).
Principal Exclusion Criteria:
- 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, or uncontrolled 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.
- Participants who have previously received allogenic stem cell transplant, or
participant has received autologous stem cell transplant within 3 months before the
first dose of study intervention.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Perth
Zip:
WA 6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hamilton
Zip:
L8V 5C2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Shenyang
Zip:
110004
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lille
Zip:
59037
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Nantes
Zip:
44000
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Freiburg
Zip:
79106
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lübeck
Zip:
23538
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nürnberg
Zip:
90419
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wuerzburg
Zip:
97080
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nagoya-shi
Zip:
467-8602
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yamagata-shi
Zip:
990-9585
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pamplona
Zip:
31005
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Start date:
December 5, 2023
Completion date:
November 11, 2025
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06106945
