Ireland
--:--IST
Recruiting Phase 1/2

AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma

NCT06106945 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1/2
Started
2023-12-05
Last updated
2026-08-19

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

AZD0305Elranatamab →Pomalidomide →Dexamethasone →

AZD0305: AZD0305 Investigational product

Elranatamab: Module 2 Investigational product

Pomalidomide: Module 3 Standard of Care (background treatment)

Dexamethasone: Module 3 Standard of Care (background treatment)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key 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 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 The above is a summary of key criteria, other inclusion criteria details may apply Key Exclusion Criteria: * 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 The above is a summary of key criteria, other exclusion criteria details may apply

Primary outcome measure(s)

  • Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only) — 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)
    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
  • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) — From time of Informed consent to 30 days post end of treatment
    Number of patients with adverse events and serious adverse events by system organ class and preferred term
  • Frequency of dose modifications, dose delays, and treatment discontinuations due to AEs (Module 2 and Module 3) — From first dose of study treatment until End of treatment (EOT), assessed up to approximately 2 years (each cycle is 28 days)
    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.

Trial sites (43)

FacilityCityRegionStatus
Research Site Duarte California Recruiting
Research Site Irvine California Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Ann Arbor Michigan Recruiting
Research Site St Louis Missouri Withdrawn
Research Site New York New York Recruiting
Research Site Philadelphia Pennsylvania Recruiting
Research Site Fairfax Virginia Recruiting
Research Site Fitzroy Australia Recruiting
Research Site Melbourne Australia Recruiting
Research Site Nedlands Australia Recruiting
Research Site Wollongong Australia Not Yet Recruiting
Research Site Salvador Brazil Not Yet Recruiting
Research Site São Paulo Brazil Not Yet Recruiting
Research Site São Paulo Brazil Not Yet Recruiting
Research Site Hamilton Ontario Recruiting
Research Site Ottawa Ontario Recruiting
Research Site Toronto Ontario Not Yet Recruiting
Research Site Montreal Quebec Recruiting
Research Site Nova Scotia Canada Not Yet Recruiting
Research Site Beijing China Recruiting
Research Site Changsha China Recruiting
Research Site Guangzhou China Recruiting
Research Site Shenyang China Recruiting
Research Site Lille France Recruiting
Research Site Nantes France Recruiting
Research Site Essen Germany Recruiting
Research Site Freiburg im Breisgau Germany Withdrawn
Research Site Hamburg Germany Recruiting
Research Site Heidelberg Germany Not Yet Recruiting
Research Site Lübeck Germany Recruiting
Research Site Nuremberg Germany Recruiting
Research Site Tübingen Germany Not Yet Recruiting
Research Site Würzburg Germany Recruiting
Research Site Kashiwa Japan Recruiting
Research Site Nagoya Japan Recruiting
Research Site Yamagata Japan Recruiting
Research Site Badalona Spain Not Yet Recruiting
Research Site Madrid Spain Recruiting

+ 3 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06106945 on ClinicalTrials.gov ↗ ← All trials in Spain