Multiple MyelomaPhase 1NCT05646836
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing Cevostamab, XmAb24306 and Tocilizumab in people with Multiple Myeloma, run by Genentech, Inc. at 13 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with cevostamab in participants with relapsed/refractory multiple myeloma (R/R MM) who have received a minimum of three prior treatments, including at least one immunomodulatory drug (IMiD)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Cevostamab, XmAb24306 and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 21 Mar 2023to 18 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
Australia3 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000
Alfred Hospital
Melbourne, Victoria, 3004
Greece2 sites
Evangelismos General Hospital of Athens
Athens, 106 76
University of Athens, Hematological Clinic,
Athens, 115 28
Israel2 sites
Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, 64239
South Korea2 sites
Severance Hospital, Yonsei University
Seoul, 03722
Asan Medical Center - PPDS
Seoul, 05505
Spain2 sites
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
About this study
Official 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
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with cevostamab in participants with relapsed/refractory multiple myeloma (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.
- Conditions
- Multiple Myeloma
- Being tested
- Cevostamab, XmAb24306, Tocilizumab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CevostamabDrug
Also called RO7187797
Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
XmAb24306Drug
Also called RO7310729
XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
TocilizumabDrug
Also called Actemra, RoActemra
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab | Experimental | Participants will receive escalating doses of XmAb24306 with a fixed dose regimen for cevostamab up to the maximum tolerated dose (MTD). After dose escalation has been completed, up to two expansion cohorts each investigating different XmAb24306 doses in combination with cevostamab may be enrolled. Receives: Drug: Cevostamab; Drug: XmAb24306; Drug: Tocilizumab |
| Arm B: Single-Agent Cevostamab Expansion | Experimental | Participants will receive cevostamab alone. Receives: Drug: Cevostamab; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AEs)
Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and Cytokine Release Syndrome (CRS), will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Measured: Up to approximately 3 years
Secondary outcomes (6)
Serum Concentration of XmAb24306
Measured: Up to approximately 3 years
Serum Concentration of Cevostamab
Measured: Up to approximately 3 years
Objective Response Rate (ORR)
ORR will be determined by the investigator according to International Myeloma Working Group (IMWG) criteria.
Measured: Up to approximately 3 years
Rate of Complete Response (CR)/ Stringent Complete Response (sCR)
Rate of CR/sCR will be determined by the investigator.
Measured: Up to approximately 3 years
Rate of Very Good Partial Response (VGPR)
Rate of VGPR will be determined by the investigator.
Measured: Up to approximately 3 years
Percentage of Participants With Anti-Drug Antibodies (ADA) to XmAb24306 and Cevostamab
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start21 Mar 2023
- Primary completion18 Nov 2026 (estimated)
- Study completion18 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646836
- Sponsor's protocol ID
- GO43980
- Other IDs
- 2022-001204-18, 2023-505212-38-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05646836
- Acronym / sponsor ID
- GO43980
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 18 Nov 2026 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with cevostamab in participants with relapsed/refractory multiple myeloma (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab | Experimental | Drug: Cevostamab, Drug: XmAb24306, Drug: TocilizumabParticipants will receive escalating doses of XmAb24306 with a fixed dose regimen for cevostamab up to the maximum tolerated dose (MTD). After dose escalation has been completed, up to two expansion cohorts each investigating different XmAb24306 doses in combination with cevostamab may be enrolled. |
| Arm B: Single-Agent Cevostamab Expansion | Experimental | Drug: Cevostamab, Drug: TocilizumabParticipants will receive cevostamab alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CevostamabAlso: RO7187797Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response. | Drug | Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab, Arm B: Single-Agent Cevostamab Expansion |
| XmAb24306Also: RO7310729XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response. | Drug | Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab |
| TocilizumabAlso: Actemra, RoActemraTocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary. | Drug | Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab, Arm B: Single-Agent Cevostamab Expansion |
Primary outcome
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 3 years
Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and Cytokine Release Syndrome (CRS), will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
6 secondary outcomes
Serum Concentration of XmAb24306
Time frame: Up to approximately 3 years
Serum Concentration of Cevostamab
Time frame: Up to approximately 3 years
Objective Response Rate (ORR)
Time frame: Up to approximately 3 years
Rate of Complete Response (CR)/ Stringent Complete Response (sCR)
Time frame: Up to approximately 3 years
Rate of Very Good Partial Response (VGPR)
Time frame: Up to approximately 3 years
Percentage of Participants With Anti-Drug Antibodies (ADA) to XmAb24306 and Cevostamab
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cevostamab, XmAb24306 and Tocilizumab in people with Multiple Myeloma, run by Genentech, Inc. at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia, Greece, Israel, South Korea, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events (AEs) (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.