Multiple MyelomaPhase 1NCT05243342
A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing XmAb24306 and Daratumumab in people with Multiple Myeloma, run by Genentech, Inc. at 7 sites in 4 countries.
Trial summary
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… 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?
- XmAb24306 and Daratumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 28 Apr 2022to 10 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Australia2 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Alfred Hospital
Melbourne, Victoria, 3004
Denmark2 sites
Odense Universitetshospital
Odense C, Region Syddanmark, 5000
Sygehus Lillebælt, Vejle
Vejle, Region Syddanmark, 7100
Spain2 sites
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitari Vall d'Hebron
Barcelona, 08035
About this study
Official title: A Phase Ib, Open-Label, Multicenter, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Patients With Relapsed/Refractory Multiple Myeloma
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.
- Conditions
- Multiple Myeloma
- Being tested
- XmAb24306, Daratumumab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb24306Drug
Also called RO7310729
XmAb24306 will be given via intravenous (IV) infusion
DaratumumabDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Participants will receive escalating doses of XmAb24306 with daratumumab up to the maximum tolerated dose (MTD) Receives: Drug: XmAb24306; Drug: Daratumumab |
| Dose expansion | Experimental | Participants will receive XmAb24306 with daratumumab at the recommended phase 2 dose (RP2D) Receives: Drug: XmAb24306; Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with adverse events (AEs)
Measured: Up to approximately 3 years
Secondary outcomes (4)
Serum concentration of XmAb24306
Measured: Baseline to approximately 3 years
Objective response rate (ORR)
Measured: Baseline to approximately 3 years
Prevalence of XmAb24306 anti-drug antibodies (ADAs)
Measured: Baseline to approximately 3 years
Incidence of XmAb24306 ADAs
Measured: Baseline 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 posted17 Feb 2022
- Study start28 Apr 2022
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
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
- 18 participants (actual)
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
- NCT05243342
- Sponsor's protocol ID
- GO43073
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2022
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. 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 and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05243342
- Acronym / sponsor ID
- GO43073
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 17 Feb 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: XmAb24306, Drug: DaratumumabParticipants will receive escalating doses of XmAb24306 with daratumumab up to the maximum tolerated dose (MTD) |
| Dose expansion | Experimental | Drug: XmAb24306, Drug: DaratumumabParticipants will receive XmAb24306 with daratumumab at the recommended phase 2 dose (RP2D) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| XmAb24306Also: RO7310729XmAb24306 will be given via intravenous (IV) infusion | Drug | Dose escalation, Dose expansion |
| DaratumumabParticipants 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) | Drug | Dose escalation, Dose expansion |
Primary outcome
Percentage of participants with adverse events (AEs)
Time frame: Up to approximately 3 years
4 secondary outcomes
Serum concentration of XmAb24306
Time frame: Baseline to approximately 3 years
Objective response rate (ORR)
Time frame: Baseline to approximately 3 years
Prevalence of XmAb24306 anti-drug antibodies (ADAs)
Time frame: Baseline to approximately 3 years
Incidence of XmAb24306 ADAs
Time frame: Baseline to approximately 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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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
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XmAb24306 and Daratumumab in people with Multiple Myeloma, run by Genentech, Inc. at 7 sites in 4 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, Denmark, Spain, Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 17 Feb 2025.