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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-28

Study Completion Date

2024-07-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalation

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

Group Type EXPERIMENTAL

XmAb24306

Intervention Type DRUG

XmAb24306 will be given via intravenous (IV) infusion

Daratumumab

Intervention Type DRUG

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)

Dose expansion

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

Group Type EXPERIMENTAL

XmAb24306

Intervention Type DRUG

XmAb24306 will be given via intravenous (IV) infusion

Daratumumab

Intervention Type DRUG

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)

Interventions

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XmAb24306

XmAb24306 will be given via intravenous (IV) infusion

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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RO7310729

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No