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

Primary Purpose

Multiple Myeloma

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

XmAb24306

Daratumumab

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Royal Adelaide HospitalRecruiting
Alfred HospitalRecruiting
Oslo Universitetssykehus HF; Ullevål sykehusRecruiting
Hospital Universitari Vall d'HebronRecruiting
Complejo Asistencial Universitario de Salamanca ? H. ClinicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Dose escalation

Dose expansion

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of participants with adverse events (AEs)

Secondary Outcome Measures

Serum concentration of XmAb24306

Objective response rate (ORR)

Prevalence of XmAb24306 anti-drug antibodies (ADAs)

Incidence of XmAb24306 ADAs

Full Information

NCT ID

NCT05243342

First Posted

February 1, 2022

Last Updated

September 1, 2023

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05243342

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 28, 2022 (Actual)

Primary Completion Date

January 1, 2026 (Anticipated)

Study Completion Date

July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dose escalation

Arm Type

Experimental

Arm Description

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

Arm Title

Dose expansion

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

XmAb24306

Other Intervention Name(s)

RO7310729

Intervention Description

XmAb24306 will be given via intravenous (IV) infusion

Intervention Type

Drug

Intervention Name(s)

Daratumumab

Intervention Description

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)

Primary Outcome Measure Information:

Title

Percentage of participants with adverse events (AEs)

Time Frame

Up to approximately 3 years

Secondary Outcome Measure Information:

Title

Serum concentration of XmAb24306

Time Frame

Baseline to approximately 3 years

Title

Objective response rate (ORR)

Time Frame

Baseline to approximately 3 years

Title

Prevalence of XmAb24306 anti-drug antibodies (ADAs)

Time Frame

Baseline to approximately 3 years

Title

Incidence of XmAb24306 ADAs

Time Frame

Baseline to approximately 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Reference Study ID Number: GO43073 https://forpatients.roche.com/

Phone

888-662-6728

global-roche-genentech-trials@gene.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Royal Adelaide Hospital

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Individual Site Status

Recruiting

Facility Name

Alfred Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Individual Site Status

Recruiting

Facility Name

Oslo Universitetssykehus HF; Ullevål sykehus

City

Oslo

ZIP/Postal Code

0450

Country

Norway

Individual Site Status

Recruiting

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Name

Complejo Asistencial Universitario de Salamanca ? H. Clinico

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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

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