A Phase Ib, Open-Label, Multicenter, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Patients With Relapsed/Refractory Multiple Myeloma

Who is this study for? Patients with relapsed/refractory multiple myeloma
What treatments are being studied? XmAb24306+Daratumumab
Status: Completed
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with a multiple myeloma (MM)-targeting monoclonal antibody capable of inducing antibody-dependent cellular toxicity (ADCC) in participants with relapsed or refractory (R/R) MM who have received a minimum of three prior treatments, including at least one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one anti-CD38 monoclonal antibody.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Life expectancy of at least 12 weeks

• Measurable disease, as defined by the protocol

• Participants must have received a minimum of 3 prior lines of therapy, including at least one PI, one IMiD, and an anti-CD38 monoclonal antibody

• Best response of stable disease or better with at least one prior anti-CD38 monoclonal antibody containing line of treatment

Locations
Other Locations
Australia
Royal Adelaide Hospital
Adelaide
Alfred Hospital
Melbourne
Denmark
Odense Universitetshospital
Odense C
Sygehus Lillebælt, Vejle
Vejle
Norway
Oslo Universitetssykehus HF
Oslo
Spain
Hospital Universitario Germans Trias i Pujol
Badalona
Hospital Universitari Vall d'Hebron
Barcelona
Time Frame
Start Date: 2022-04-28
Completion Date: 2024-07-10
Participants
Target number of participants: 18
Treatments
Experimental: Dose escalation
Participants will receive escalating doses of XmAb24306 with daratumumab up to the maximum tolerated dose (MTD)
Experimental: Dose expansion
Participants will receive XmAb24306 with daratumumab at the recommended phase 2 dose (RP2D)
Related Therapeutic Areas
Sponsors
Leads: Genentech, Inc.

This content was sourced from clinicaltrials.gov