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RecruitingLast updated: 22 January 2024

Stev-eX: This phase I study is evaluating how safe, tolerable and effective a new drug (XmAb24306) is in combination with immunotherapy (cevostamab) in people with relapsed or refractory multiple myeloma who have had prior treatmentA 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

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

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

Stev-eX

More information

Trial Identifiers

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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

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 a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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