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

Genentech

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Daratumumab; Drug: XmAb24306

Study type: Interventional

Funder types: Industry

Identifiers

NCT05243342

GO43073

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Dose escalation

Experimental group

Description:

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

Treatment:

Drug: XmAb24306

Drug: Daratumumab

Dose expansion

Experimental group

Description:

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

Treatment:

Drug: XmAb24306

Drug: Daratumumab