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New drug AZD0305 takes on multiple myeloma in early trial

NCT ID NCT06106945

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 4 times

Summary

This study tests a new medicine called AZD0305 in people with multiple myeloma, a type of blood cancer. The trial has two phases: first, finding a safe dose, then seeing how well it works alone or with other cancer drugs. About 226 adults will take part. The goal is to control the disease, not cure it, as ongoing treatment may be needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 226 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    41 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Duarte, California, 91010, United States

  • Research Site

    RECRUITING

    Irvine, California, 92618, United States

  • Research Site

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Research Site

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    WITHDRAWN

    St Louis, Missouri, 63110, United States

  • Research Site

    RECRUITING

    New York, New York, 10065, United States

  • Research Site

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Research Site

    RECRUITING

    Fitzroy, VIC3065, Australia

  • Research Site

    RECRUITING

    Melbourne, 3000, Australia

  • Research Site

    RECRUITING

    Nedlands, 6009, Australia

  • Research Site

    NOT_YET_RECRUITING

    Wollongong, 2500, Australia

  • Research Site

    NOT_YET_RECRUITING

    Salvador, 41253-190, Brazil

  • Research Site

    NOT_YET_RECRUITING

    São Paulo, 04537-080, Brazil

  • Research Site

    NOT_YET_RECRUITING

    São Paulo, 05652000, Brazil

  • Research Site

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Research Site

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • Research Site

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    NOT_YET_RECRUITING

    Nova Scotia, B3H 1V7, Canada

  • Research Site

    RECRUITING

    Beijing, 100044, China

  • Research Site

    RECRUITING

    Changsha, 410013, China

  • Research Site

    RECRUITING

    Guangzhou, 510060, China

  • Research Site

    RECRUITING

    Shenyang, 110134, China

  • Research Site

    RECRUITING

    Lille, 59037, France

  • Research Site

    RECRUITING

    Nantes, 44000, France

  • Research Site

    RECRUITING

    Essen, 45147, Germany

  • Research Site

    WITHDRAWN

    Freiburg im Breisgau, 79106, Germany

  • Research Site

    RECRUITING

    Hamburg, 20246, Germany

  • Research Site

    NOT_YET_RECRUITING

    Heidelberg, 69120, Germany

  • Research Site

    RECRUITING

    Lübeck, 23538, Germany

  • Research Site

    RECRUITING

    Nuremberg, 90419, Germany

  • Research Site

    NOT_YET_RECRUITING

    Tübingen, 72076, Germany

  • Research Site

    RECRUITING

    Würzburg, 97080, Germany

  • Research Site

    RECRUITING

    Kashiwa, 277-8577, Japan

  • Research Site

    RECRUITING

    Nagoya, 467-8602, Japan

  • Research Site

    RECRUITING

    Yamagata, 990-9585, Japan

  • Research Site

    NOT_YET_RECRUITING

    Badalona, 8916, Spain

  • Research Site

    RECRUITING

    Madrid, 28027, Spain

  • Research Site

    RECRUITING

    Madrid, 28041, Spain

  • Research Site

    RECRUITING

    Pamplona, 31005, Spain

  • Research Site

    RECRUITING

    Salamanca, 37007, Spain

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