Health TrialsbyHealthPanel

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

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • AZD0305

    Drug

    AZD0305 Investigational product

  • Elranatamab

    Drug

    Module 2 Investigational product

  • Pomalidomide

    Drug

    Module 3 Standard of Care (background treatment)

  • Dexamethasone

    Drug

    Module 3 Standard of Care (background treatment)

Treatment groups

226 Participants
are divided into 3 treatment groups
Group A: AZD0305 monotherapyExperimental treatment 1 intervention
Group B: AZD0305 + ElranatamabExperimental treatment 2 interventions
Group C: AZD0305 + Pomalidomide and DexamethasoneExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only)

A DLT is any toxicity occuring from the first dose of AZD0305 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

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)
2

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

Time frame
From time of Informed consent to 30 days post end of treatment
3

Frequency of dose modifications, dose delays, and treatment discontinuations due to AEs (Module 2 and Module 3)

Number and percentage of participants with dose modifications, dose delays, and permanent discontinuations due to adverse events (for AZD0305 and combination agent\[s\], as applicable), per protocol-defined dose modification rules.

Time frame
From first dose of study treatment until End of treatment (EOT), assessed up to approximately 2 years (each cycle is 28 days)

Secondary outcomes

1

Phase Ia: Objective Response Rate (ORR)

The percentage of patients with a confirmed investigator assessed sCR, CR, VGPR or PR according to IMWG criteria

Time frame
From first dose of AZD0305 to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)
2

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

Time frame
From the first documented response to confirmed progressive disease or death (approximately 2 years)
3

Phase Ia: Progression free Survival (PFS)

The time from first dose until IMWG defined disease progression or death

Time frame
From first dose of AZD0305 to progressive disease or death in the absence of disease progression (approximately 2 years)
4

Phase Ia: Overall Survival (OS)

The time from the date of the first dose of study treatment until death due to any cause

Time frame
From first dose of AZD0305 to death (approximately 2 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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