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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
Basic Details
Sponsor
Genentech, Inc.
Phase
Phase 1
Trial Identifier
NCT05243342, GO43073
Condition
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 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 Criteria
All
≥18 Years
No
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
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com