Recruiting
Phase 1
Phase 2

AZD0305

Sponsor:

AstraZeneca

Code:

NCT06106945

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD0305

Elranatamab

Pomalidomide

Dexamethasone

Study Details

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.

Conditions

Multiple Myeloma

Study ID

NCT06106945

Start date

Dec 5, 2023

Status verified date

Aug, 2026

Completion date

Aug 16, 2027

Anticipated

Primary completion date

Aug 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

226 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AZD0305 monotherapy

Module 1:

Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be administered at specified dose levels.

experimental: AZD0305 + Elranatamab

Module2:

Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with elranatamab, following the module-specific dosing.

experimental: AZD0305 + Pomalidomide and Dexamethasone

Module3:

Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with pomalidomide and dexamethasone, following the module-specific dosing.

Interventions

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)

Primary outcome measure

  • Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: From first dose of study treatment until End of treatment (EOT), assessed up to approximately 2 years (each cycle is 28 days) ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Duarte, California, United States, 91010

Research Site

Recruiting

Irvine, California, United States, 92618

Research Site

Recruiting

Atlanta, Georgia, United States, 30322

Research Site

Recruiting

Boston, Massachusetts, United States, 02215

Research Site

Recruiting

Ann Arbor, Michigan, United States, 48109

Research Site

Recruiting

New York, New York, United States, 10065

Research Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Research Site

Recruiting

Fairfax, Virginia, United States, 22031

Research Site

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Research Site

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Research Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

AstraZeneca

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • GPRC5D
  • ADC
  • AZD0305
  • Multiple Myeloma
  • MM
  • MMAE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-19.