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

PHASE1PHASE2RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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).
  • 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.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-12-05

    Primary completion: 2025-11-11

    Study completion finish: 2025-11-11

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

      PHASE2

    trial

    Trial ID

    NCT06106945

    Intervention or treatment

    DRUG: AZD0305

    Conditions

    • Multiple Myeloma

    Find a site

    Closest Location:

    Research Site

    Research sites nearby

    Select from list below to view details:

    • Research Site

      Melbourne, Not Specified, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: AZD0305 monotherapy
    • Module 1:
    • Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be prescribed at specified dose levels.
    DRUG: AZD0305
    • AZD0305

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    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 toxicitiesFrom first dose of study treatment until the end of Cycle 1
    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 termFrom time of Informed consent to 30 days post end of treatment

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Phase Ia: Objective Response Rate (ORR)The percentage of patients with a confirmed investigator assessed sCR, CR, VGPR or PR according to IMWG criteriaFrom first dose of AZD0305 to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)
    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 progressionFrom the first documented response to confirmed progressive disease or death (approximately 2 years)
    Phase Ia: Progression free Survival (PFS)The time from first dose until IMWG defined disease progression or deathFrom first dose of AZD0305 to progressive disease or death in the absence of disease progression (approximately 2 years)
    Phase Ia: Overall Survival (OS)The time from the date of the first dose of study treatment until death due to any causeFrom first dose of AZD0305 to death (approximately 2 years)
    Phase Ia: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC)Area under the plasma concentration-time curveFrom the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
    Phase Ia: Pharmacokinetics of AZD0305: Maximum plasma concentration of the study drug (Cmax)Maximum observed plasma concentration of the study drugFrom the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
    Phase Ia: Pharmacokinetics of AZD0305: Time to maximum plasma concentration of the study drug (tmax)Time to maximum observed plasma concentration of the study drugFrom the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
    Phase Ia: Pharmacokinetics of AZD0305: ClearanceA pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit timeFrom the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
    Phase Ia: Pharmacokinetics of AZD0305: Terminal elimination half-life (t 1/2)Terminal elimination half-lifeFrom the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
    Phase Ia: Immunogenicity of AZD0305The number and percentage of participants who develop ADAsFrom the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
    Phase Ib: Objective Response Rate (ORR)The percentage of patients with a confirmed investigator assessed sCR, CR, VGPR or PR according to IMWG criteriaFrom randomization to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)
    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 progressionFrom randomization to confirmed progressive disease or death (approximately 2 years)
    Phase Ib: Progression free Survival (PFS)The time from randomization until IMWG defined disease progression or deathFrom randomization to progressive disease or death in the absence of disease progression (approximately 2 years)
    Phase Ib: Overall Survival (OS)The time from randomization until death due to any causeFrom randomization to death (approximately 2 years)
    Phase Ib: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC)Area under the plasma concentration-time curveFrom randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
    Phase Ib: Pharmacokinetics of AZD0305: Maximum plasma concentration of the study drug (Cmax)Maximum observed plasma concentration of the study drugFrom randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
    Phase Ib: Pharmacokinetics of AZD0305: Time to maximum plasma concentration of the study drug (tmax)Time to maximum observed plasma concentration of the study drugFrom randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
    Phase Ib: Pharmacokinetics of AZD0305: ClearanceA pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit timeFrom randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years
    Phase Ib: Pharmacokinetics of AZD0305: Terminal elimination half-life (t 1/2)Terminal elimination half-lifeFrom randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
    Phase Ib: Immunogenicity of AZD0305The number and percentage of participants who develop ADAsFrom randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)

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    References

    Clinical Trials Gov: AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma

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