Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
Eligible participants must 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. This study as two experimental arms.
Experimental Arm A is a dose-escalation and expansion study of XmAb24306 + Cevostamab. Participants will receive escalating doses of XmAb24306 (administered intravenously on a 28-day cycle) plus a fixed dose regimen for cevostamab (administered intravenously on a 28-day cycle) up to the maximum tolerated dose. After dose escalation has been completed, up to two expansion cohorts each investigating different XmAb24306 doses in combination with cevostamab may be enrolled.
Experimental Arm B is a single-agent cevostamab expansion arm. Participants will receive cevostamab alone (administered intravenously on a 28-day cycle). In both arms, tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
Conditions
This trial is treating patients with relapsed or refractory multiple myeloma
Eligibility
Inclusion
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- 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.
- Documented evidence of progressive disease on or after the last prior therapy, or participants who were intolerant to the last prior therapy.
- Measurable disease, as defined by the protocol
- Participants agree to follow contraception or abstinence requirements as defined in the protocol
Exclusion
- Any anti-cancer therapy within 3 weeks prior to initiation of study treatment with exception defined by the protocol
- Participants with autologous stem cell transplantation (SCT) within 100 days prior to first dose of study treatment
- Participants with prior allogeneic SCT or solid organ transplantation
- Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
- Active or history of autoimmune disease
- Participants with current or history of Central Nervous System (CNS) disease, or current CNS involvement by Multiple Myeloma (MM)
- Significant cardiovascular disease
- Participants with known clinically significant liver disease
- Symptomatic active pulmonary disease requiring supplemental oxygen
- Known active infection requiring intravenous anti-microbial therapy within 14 days prior to first study drug administration
- Any episode of active, symptomatic COVID-19 infection, or requiring treatment with IV antivirals for COVID-19 (not including COVID-19 primary prophylaxis) within 14 days, prior to first study treatment
- Other protocol defined inclusion/exclusion criteria may apply
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Genentech
Scientific Title
A Phase Ib, Open-label, Multicenter Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Patients With Relapsed/Refractory Multiple Myeloma
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