AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
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
2 other identifiers
interventional
226
9 countries
43
Brief 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 efficacy of AZD0305 as monotherapy and in combination with other anticancer agents in participants with MM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-myeloma
Started Dec 2023
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2023
CompletedFirst Posted
Study publicly available on registry
October 30, 2023
CompletedStudy Start
First participant enrolled
December 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 16, 2027
July 13, 2026
July 1, 2026
3.7 years
October 11, 2023
July 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only)
A DLT is any toxicity occuring from the first dose of AZD0305 up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation and which includes, any death not clearly due to the underlying disease or extraneous causes, pre-defined haematological and non-haematological toxicities
From first dose of AZD0305 until the end of Cycle 1. Cycle 1 (the DLT assessment period is 21 days for Module 1 Group A and 28 days for Module 1 Group B, Module 2, and Module 3)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of patients with adverse events and serious adverse events by system organ class and preferred term
From time of Informed consent to 30 days post end of treatment
Frequency of dose modifications, dose delays, and treatment discontinuations due to AEs (Module 2 and Module 3)
Number and percentage of participants with dose modifications, dose delays, and permanent discontinuations due to adverse events (for AZD0305 and combination agent\[s\], as applicable), per protocol-defined dose modification rules.
From first dose of study treatment until End of treatment (EOT), assessed up to approximately 2 years (each cycle is 28 days)
Secondary Outcomes (26)
Phase Ia: Objective Response Rate (ORR)
From first dose of AZD0305 to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)
Phase Ia: Duration of response (DoR)
From the first documented response to confirmed progressive disease or death (approximately 2 years)
Phase Ia: Progression free Survival (PFS)
From first dose of AZD0305 to progressive disease or death in the absence of disease progression (approximately 2 years)
Phase Ia: Overall Survival (OS)
From first dose of AZD0305 to death (approximately 2 years)
Phase Ia: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC)
From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
- +21 more secondary outcomes
Study Arms (3)
AZD0305 monotherapy
EXPERIMENTALModule 1: Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be administered at specified dose levels.
AZD0305 + Elranatamab
EXPERIMENTALModule2: Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with elranatamab, following the module-specific dosing.
AZD0305 + Pomalidomide and Dexamethasone
EXPERIMENTALModule3: Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with pomalidomide and dexamethasone, following the module-specific dosing.
Interventions
Module 3 Standard of Care (background treatment)
Module 3 Standard of Care (background treatment)
AZD0305 Investigational product
Eligibility Criteria
You 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, or 1-3 prior lines in modules 2 and 3, with additional module-specific requirements related to prior lines of therapy
You may not qualify if:
- 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;
- 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;
- 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 JC virus infection resulting in PML;
- Participants with a known hypersensitivity to AZD0305 or any of the excipients of the product or to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior monoclonal antibody therapy;
- Participants who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and/or other administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (43)
Research Site
Duarte, California, 91010, United States
Research Site
Irvine, California, 92618, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
Boston, Massachusetts, 02215, United States
Research Site
Ann Arbor, Michigan, 48109, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
New York, New York, 10065, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Fairfax, Virginia, 22031, United States
Research Site
Fitzroy, VIC3065, Australia
Research Site
Melbourne, 3000, Australia
Research Site
Nedlands, 6009, Australia
Research Site
Wollongong, 2500, Australia
Research Site
Salvador, 41253-190, Brazil
Research Site
São Paulo, 04537-080, Brazil
Research Site
São Paulo, 05652000, Brazil
Research Site
Hamilton, Ontario, L8V 5C2, Canada
Research Site
Ottawa, Ontario, K1H 8L6, Canada
Research Site
Toronto, Ontario, M5G 2M9, Canada
Research Site
Montreal, Quebec, H4A 3J1, Canada
Research Site
Nova Scotia, B3H 1V7, Canada
Research Site
Beijing, 100044, China
Research Site
Changsha, 410013, China
Research Site
Guangzhou, 510060, China
Research Site
Shenyang, 110134, China
Research Site
Lille, 59037, France
Research Site
Nantes, 44000, France
Research Site
Essen, 45147, Germany
Research Site
Freiburg im Breisgau, 79106, Germany
Research Site
Hamburg, 20246, Germany
Research Site
Heidelberg, 69120, Germany
Research Site
Lübeck, 23538, Germany
Research Site
Nuremberg, 90419, Germany
Research Site
Tübingen, 72076, Germany
Research Site
Würzburg, 97080, Germany
Research Site
Kashiwa, 277-8577, Japan
Research Site
Nagoya, 467-8602, Japan
Research Site
Yamagata, 990-9585, Japan
Research Site
Badalona, 8916, Spain
Research Site
Madrid, 28027, Spain
Research Site
Madrid, 28041, Spain
Research Site
Pamplona, 31005, Spain
Research Site
Salamanca, 37007, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Masking Details
- No Masking
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2023
First Posted
October 30, 2023
Study Start
December 5, 2023
Primary Completion (Estimated)
August 16, 2027
Study Completion (Estimated)
August 16, 2027
Last Updated
July 13, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.