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

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT06106945
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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)

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 efficacy of AZD0305 as monotherapy and in combination with other anticancer agents in participants with MM.

Key Dates

Start date
Dec 5, 2023
Status verified
May 2026
Primary completion
Aug 16, 2027
Completion
Aug 16, 2027

Study Design

Enrollment
226 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD0305 monotherapy
    Module 1: Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be administered at specified dose levels.
  • Experimental: AZD0305 + Elranatamab
    Module2: Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with elranatamab, following the module-specific dosing.
  • Experimental: AZD0305 + Pomalidomide and Dexamethasone
    Module3: Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with pomalidomide and dexamethasone, following the module-specific dosing.

Primary Outcome Measure

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

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteIrvineCalifornia92618-
Research SiteAtlantaGeorgia30322-
Research SiteBostonMassachusetts02215-
Research SiteAnn ArborMichigan48109-
Research SiteSt LouisMissouri63110-
Research SiteNew YorkNew York10065-
Research SitePhiladelphiaPennsylvania19104-
Research SiteFairfaxVirginia22031-

Find similar trials in Duarte, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Research Site· Duarte, CAResearch Site· Irvine, CAResearch Site· Atlanta, GAResearch Site· Boston, MAResearch Site· Ann Arbor, MIResearch Site· St Louis, MO

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