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NCT06106945PHASE1, PHASE2Recruiting

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

AstraZeneca

Start Date

12/5/2023

Completion Date

8/16/2027

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.

Detailed Description

This study will follow a modular protocol design evaluating AZD0305 as monotherapy and in combination with other anticancer agents. The protocol may be amended in the future to incorporate further monotherapy expansion at the recommended Phase 2 dose (RP2D) in Phase II, and/or additional modules investigating AZD0305 in combination with other anticancer agents. The study consists of 3 modules: * Module 1 (AZD0305 monotherapy), * Module 2 (AZD0305 in combination with elranatamab) * Module 3 (AZD0305 in combination with pomalidomide and dexamethasone \[Pd\])

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

AZD0305

DRUG

Elranatamab

DRUG

Pomalidomide

DRUG

Dexamethasone

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Conditions

Multiple Myeloma

Locations

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

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