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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06106945
Other study ID # D7230C00001
Secondary ID 2023-508590-89-0
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date December 5, 2023
Est. completion date November 11, 2025

Study information

Verified date June 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 preliminary efficacy of AZD0305 in participants with RRMM.


Description:

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 preliminary efficacy of AZD0305 in participants with RRMM. This study will follow a modular protocol design evaluating AZD0305 as monotherapy and in combination with other anticancer agents. The study includes dose escalation and dose expansion phases. This study will enroll subjects with RRMM who received at least 3 prior lines of treatment including at least one proteasome inhibitor (PI), one immunomodulator (IMiD), and an anti-CD38 antibody. Subjects will be administered AZD0305 intravenously.


Recruitment information / eligibility

Status Recruiting
Enrollment 84
Est. completion date November 11, 2025
Est. primary completion date November 11, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Principal 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 (ECOG) performance status of = 2. - 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 of the following measurable disease criteria: 1. Serum M-protein level = 0.5 g/dL. 2. Urine M-protein level = 200 mg/24h. 3. Serum immunoglobulin free light chain = 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio. - Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP. - Participants must have received at least 3 prior lines of treatment which include a proteasome inhibitor (e.g., bortezomib), an immunomodulator (e.g., lenalidomide), and an anti-CD38 antibody (e.g., daratumumab). Principal Exclusion Criteria: - Participants exhibiting clinical signs of central nervous system involvement of MM. - Participants with known COPD, or previous history of ILD. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AZD0305
AZD0305

Locations

Country Name City State
Australia Research Site Melbourne
Australia Research Site Perth
Canada Research Site Hamilton Ontario
Canada Research Site Montreal Quebec
China Research Site Beijing
France Research Site Lille
France Research Site Nantes
Germany Research Site Freiburg
Germany Research Site Hamburg
Germany Research Site Lübeck
Germany Research Site Nürnberg
Germany Research Site Wuerzburg
Japan Research Site Kashiwa
Japan Research Site Nagoya-shi
Japan Research Site Yamagata-shi
Spain Research Site Madrid
Spain Research Site Pamplona
Spain Research Site Salamanca
United States Research Site Ann Arbor Michigan
United States Research Site Atlanta Georgia
United States Research Site Duarte California
United States Research Site Fairfax Virginia
United States Research Site Irvine California
United States Research Site New York New York
United States Research Site Philadelphia Pennsylvania
United States Research Site Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  France,  Germany,  Japan,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only) A DLT is defined as any toxicity that occurs from the first dose of study treatment 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 study treatment until the end of Cycle 1
Primary 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
Secondary Phase Ia: Objective Response Rate (ORR) The percentage of patients with a confirmed investigator assessed sCR, CR, VGPR or PR according to IMWG criteria From first dose of AZD0305 to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)
Secondary Phase Ia: Duration of response (DoR) The time from the date of first response until date of disease progression or death in the absence of disease progression From the first documented response to confirmed progressive disease or death (approximately 2 years)
Secondary Phase Ia: Progression free Survival (PFS) The time from first dose until IMWG defined disease progression or death From first dose of AZD0305 to progressive disease or death in the absence of disease progression (approximately 2 years)
Secondary Phase Ia: Overall Survival (OS) The time from the date of the first dose of study treatment until death due to any cause From first dose of AZD0305 to death (approximately 2 years)
Secondary Phase Ia: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC) Area under the plasma concentration-time curve From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary Phase Ia: Pharmacokinetics of AZD0305: Maximum plasma concentration of the study drug (Cmax) Maximum observed plasma concentration of the study drug From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary Phase Ia: Pharmacokinetics of AZD0305: Time to maximum plasma concentration of the study drug (tmax) Time to maximum observed plasma concentration of the study drug From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary Phase Ia: Pharmacokinetics of AZD0305: Clearance A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary Phase Ia: Pharmacokinetics of AZD0305: Terminal elimination half-life (t 1/2) Terminal elimination half-life From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary Phase Ia: Immunogenicity of AZD0305 The number and percentage of participants who develop ADAs From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary Phase Ib: Objective Response Rate (ORR) The percentage of patients with a confirmed investigator assessed sCR, CR, VGPR or PR according to IMWG criteria From randomization to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)
Secondary Phase Ib: Duration of response (DoR) The time from date of first response until date of disease progression or death in the absence of disease progression From randomization to confirmed progressive disease or death (approximately 2 years)
Secondary Phase Ib: Progression free Survival (PFS) The time from randomization until IMWG defined disease progression or death From randomization to progressive disease or death in the absence of disease progression (approximately 2 years)
Secondary Phase Ib: Overall Survival (OS) The time from randomization until death due to any cause From randomization to death (approximately 2 years)
Secondary Phase Ib: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC) Area under the plasma concentration-time curve From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary Phase Ib: Pharmacokinetics of AZD0305: Maximum plasma concentration of the study drug (Cmax) Maximum observed plasma concentration of the study drug From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary Phase Ib: Pharmacokinetics of AZD0305: Time to maximum plasma concentration of the study drug (tmax) Time to maximum observed plasma concentration of the study drug From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary Phase Ib: Pharmacokinetics of AZD0305: Clearance A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years
Secondary Phase Ib: Pharmacokinetics of AZD0305: Terminal elimination half-life (t 1/2) Terminal elimination half-life From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary Phase Ib: Immunogenicity of AZD0305 The number and percentage of participants who develop ADAs From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
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