A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose escalation Participants will receive escalating doses of XmAb24306 with daratumumab up to the maximum tolerated dose (MTD) |
Drug: XmAb24306
XmAb24306 will be given via intravenous (IV) infusion
Other Names:
Drug: Daratumumab
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)
|
| Experimental: Dose expansion Participants will receive XmAb24306 with daratumumab at the recommended phase 2 dose (RP2D) |
Drug: XmAb24306
XmAb24306 will be given via intravenous (IV) infusion
Other Names:
Drug: Daratumumab
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)
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with adverse events (AEs) [Up to approximately 3 years]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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:
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Any anti-cancer therapy within 3 weeks prior to initiation of study treatment, with exceptions defined by the protocol
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Prior allogeneic stem cell or solid organ transplantation
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Autologous stem cell transplantation within 100 days prior to initiation of study treatment
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Significant cardiovascular disease
-
Known clinically significant liver disease
-
Active or history of autoimmune disease or immune deficiency
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Known active infection requiring IV anti-microbial therapy within 14 days prior to first study drug administration
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Primary or secondary plasma cell leukemia
-
Current CNS involvement by MM
-
Other protocol defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
| 2 | Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
| 3 | Oslo Universitetssykehus HF; Ullevål sykehus | Oslo | Norway | 0450 |
Sponsors and Collaborators
- Genentech, Inc.
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GO43073