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

Active:	Yes
Cancer Type:	Multiple Myeloma Plasma cell neoplasm	NCT ID:	NCT06106945
Trial Phases:	Phase I Phase II	Protocol IDs:	D7230C00001 (primary) NCI-2023-10034 2023-508590-89-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	AstraZeneca Pharmaceuticals LP
NCI Full Details:	http://clinicaltrials.gov/show/NCT06106945

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.

Objectives

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])

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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