A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: XmAb24306; Drug: Daratumumab

• Registration Number: NCT05243342
• Lead Sponsor: Genentech, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-14
• Study First Posted: 2022-02-17
• Study Start: 2022-04-28
• Primary Completion: 2024-07-10
• Study Completion: 2024-07-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 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

Exclusion Criteria

• Any anti-cancer therapy within 3 weeks prior to initiation of study treatment, with exceptions defined by the protocol
• Prior allogeneic stem cell or solid organ transplantation
• Autologous stem cell transplantation within 100 days prior to initiation of study treatment
• Significant cardiovascular disease
• Known clinically significant liver disease
• Active or history of autoimmune disease or immune deficiency
• Known active infection requiring IV anti-microbial therapy within 14 days prior to first study drug administration
• Primary or secondary plasma cell leukemia
• Current CNS involvement by MM
• Other protocol defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose escalation	Daratumumab	Participants will receive escalating doses of XmAb24306 with daratumumab up to the maximum tolerated dose (MTD)
Dose expansion	Daratumumab	Participants will receive XmAb24306 with daratumumab at the recommended phase 2 dose (RP2D)
Dose escalation	XmAb24306	Participants will receive escalating doses of XmAb24306 with daratumumab up to the maximum tolerated dose (MTD)
Dose expansion	XmAb24306	Participants will receive XmAb24306 with daratumumab at the recommended phase 2 dose (RP2D)

Primary Outcome Measures

Name	Time	Method
Percentage of participants with adverse events (AEs)	Up to approximately 3 years

Secondary Outcome Measures

Name	Time	Method
Prevalence of XmAb24306 anti-drug antibodies (ADAs)	Baseline to approximately 3 years
Objective response rate (ORR)	Baseline to approximately 3 years
Serum concentration of XmAb24306	Baseline to approximately 3 years
Incidence of XmAb24306 ADAs	Baseline to approximately 3 years

Trial Locations

Locations (7)

Oslo Universitetssykehus HF; 🇳🇴 Oslo, Norway

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Odense Universitetshospital; 🇩🇰 Odense C, South Denmark, Denmark

Sygehus Lillebælt, Vejle; 🇩🇰 Vejle, South Denmark, Denmark

Hospital Universitario Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain