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

NCT05243342 | Completed Phase 1

• 1 other identifier: GO43073
• Study Type: interventional
• Target: 18
• Locations: 4 countries
• Sites: 7

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with adverse events (AEs)

  Up to approximately 3 years

Secondary Outcomes (4)

• Serum concentration of XmAb24306

  Baseline to approximately 3 years

• Objective response rate (ORR)

  Baseline to approximately 3 years

• Prevalence of XmAb24306 anti-drug antibodies (ADAs)

  Baseline to approximately 3 years

• Incidence of XmAb24306 ADAs

  Baseline to approximately 3 years

Study Arms (2)

Dose escalation

EXPERIMENTAL

Participants will receive escalating doses of XmAb24306 with daratumumab up to the maximum tolerated dose (MTD)

Drug: XmAb24306; Drug: Daratumumab

Dose expansion

EXPERIMENTAL

Participants will receive XmAb24306 with daratumumab at the recommended phase 2 dose (RP2D)

Drug: XmAb24306; Drug: Daratumumab

Interventions

XmAb24306 DRUG

XmAb24306 will be given via intravenous (IV) infusion

Also known as: RO7310729

Dose escalation; Dose expansion

Daratumumab DRUG

Participants will receive daratumumab via subcutaneous (SC) injection every week for Cycles 1-4, every 2 weeks for Cycles 5-12, and every 4 weeks thereafter (cycle length = 2 weeks for Cycles 1-12 and 4 weeks thereafter)

Dose escalation; Dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (7)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Odense Universitetshospital

Odense C, Region Syddanmark, 5000, Denmark

Location

Sygehus Lillebælt, Vejle

Vejle, Region Syddanmark, 7100, Denmark

Location

Oslo Universitetssykehus HF

Oslo, 0450, Norway

Location

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 17, 2022
• Study Start: April 28, 2022
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

AU (2); ES (2); DK (2); NO (1)