Multiple MyelomaPhase 1NCT04557150
A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)
A Phase 1 study testing Forimtamig in people with Multiple Myeloma, run by Hoffmann-La Roche at 20 sites in 9 countries.
Trial summary
This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. Forimtamig will be administered to participants with r/r MM for whom no standard-of-care treatment exists or who are intolerant to those established therapies. 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?
- Forimtamig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 20 sitesin 9 countries
- Study dates
- 11 Nov 2020to 17 Mar 2026
- 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
- Previously diagnosed with Multiple Myeloma (MM) based on standard criteria.
- Dose Escalation Phase and Dose Expansion Phase: Participants with r/r MM who have previously received therapy with an Immunomodulatory drug (IMiD) and Proteasome Inhibitor (PI) and are intolerant to or have no other option for standard-of-care treatment according to the Investigator.
- Life expectancy of at least 12 weeks.
- Agreement to provide protocol-specific biopsy material.
- AEs from prior anti-cancer therapy resolved to Grade =<1.
- Measurable disease.
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.
Who cannot join
- Inability to comply with protocol-mandated hospitalization and activities restrictions.
- Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after last dose of study drug.
- Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for MM treatment within 2 weeks before first forimtamig administration.
- Prior treatment with systemic immunotherapeutic agents within 2 weeks before first forimtamig administration.
- Treatment-related, immune-mediated AEs associated with prior immunotherapeutic agents.
- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks, prior to first forimtamig administration. Limited field palliative radiotherapy for bone pain or for soft tissue lesions is allowed.
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- Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to first forimtamig infusion and/or signs of chronic graft versus host disease or ongoing immunosuppressive medication.
- Prior solid organ transplantation.
- Active auto-immune disease or flare within 6 months prior to start of study treatment
- Any medical condition or abnormality in clinical laboratory tests that, in the Investigator's or Medical Monitor's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.
Trial locations and contacts
20 sites in 9 countries.
20 sites in 9 countries
Italy4 sites
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, 40138
Fond. IRCCS Istituto Nazionale Tumori
Milan, Lombardy, 20133
IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica
Naples, Campania, 80131
Instituto Clinico Humanitas
Rozzano, Lombardy, 20089
France3 sites
CHRU Lille - Hôpital Claude Huriez
Lille, 59037
CHU NANTES - Hôtel Dieu
Nantes, 44093
Hopital De Haut Leveque
Pessac, 33604
South Korea3 sites
Seoul National University Hospital
Seoul, 03080
Samsung Medical Center
Seoul, 06351
Seoul St Mary's Hospital
Seoul, 06591
Spain3 sites
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Denmark2 sites
Rigshospitalet
København Ø, 2100
Odense Universitetshospital
Odense C, 5000
United Kingdom2 sites
St James University Hospital
Leeds, LS9 7TF
University College London Hospitals NHS Foundation Trust
London, W1T 7HA
About this study
Official title: An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig (RO7425781) in Participants With Relapsed or Refractory Multiple Myeloma
This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. Forimtamig will be administered to participants with r/r MM for whom no standard-of-care treatment exists or who are intolerant to those established therapies. The study consists of two parts: dose-escalation of forimtamig (Part 1) and a randomized dose expansion of forimtamig (Part 2).
- Conditions
- Multiple Myeloma
- Being tested
- Forimtamig
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForimtamigDrug
Also called RO7425781
Forimtamig will be administered via IV/SC administration. The RP2Ds determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. Forimtamig will be administered as per the dosing schedule defined in Part I.
| Study group | Role | What they receive |
|---|---|---|
| Part I: Dose Escalation | Experimental | Participants will receive forimtamig as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion. Receives: Drug: Forimtamig |
| Part II: Dose Expansion | Experimental | Dose Expansion cohorts with IV and/or SC administration, respectively, will be initiated at the Recommended Phase 2 Doses (RP2Ds) determined in Part I: Dose Escalation phase. Receives: Drug: Forimtamig |
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 104 weeks
Percentage of Participants with Dose Limiting Toxicities (DLTs)
Measured: Cycle 1 Day 1 up to Cycle 1 Day 35
Secondary outcomes (12)
Objective Response Rate (ORR)
Measured: Up to 104 weeks
Duration of Response (DOR)
Measured: Up to 104 weeks
Progression-Free Survival (PFS)
Measured: Up to 104 weeks
Overall Survival (OS)
Measured: Up to 104 weeks
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig
Measured: Up to 104 weeks
Maximum Concentration (Cmax) of Forimtamig
Measured: Up to 104 weeks
Time of Maximum Concentration (Tmax) of Forimtamig
Measured: Up to 104 weeks
Minimum Concentration (Cmin) of Forimtamig
Measured: Up to 104 weeks
SC Bioavailability (F) of Forimtamig
Measured: Up to 104 weeks
Apparent Clearance (CL/F) of Forimtamig
Measured: Up to 104 weeks
Volume of Distribution at Steady State (Vss) of Forimtamig (IV only)
Measured: Up to 104 weeks
Area Under the Curve (AUC) at Various Time Intervals of Forimtamig
Measured: Up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start11 Nov 2020
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557150
- Sponsor's protocol ID
- BP42233
- Other IDs
- 2020-002012-46, 2023-504571-25-00, 2023
- Status last verified
- Apr 2026
- First submitted
- 17 Sep 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- 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
Publications
Kraft TE, Marrer-Berger E, Belli S, Haegel H, Schneider A, Giusti AM, Bscheider M, Jacob W, Weisser M, Blanco L, Frances N, Rossmann E, Steiner G, Azpiroz AZ, Paiva B, Martinet L, Fauti T. Patient-Centric First-in-Human Dose Selection: An Ex Vivo Minimal Anticipated Biological Effect Level Approach for T-Cell Engagers in Multiple Myeloma. Clin Pharmacol Ther. 2026 Sep;120(3):745-752. doi: 10.1002/cpt.70366. Epub 2026 Jun 17.
PubMed 42310437Eckmann J, Fauti T, Biehl M, Zabaleta A, Blanco L, Lelios I, Gottwald S, Rae R, Lechner S, Bayer C, Dekempe Q, Osl F, Carrie N, Kassem S, Lorenz S, Christopeit T, Carpy A, Bujotzek A, Broske AM, Dekhtiarenko I, Attig J, Kunz L, Cremasco F, Adelfio R, Fertig G, Dengl S, Gassner C, Bormann F, Kirstenpfad C, Kraft T, Diggelmann S, Knobloch M, Hage C, Feddersen R, Heidkamp G, Poschinger T, Mayoux M, Bernasconi L, Prosper F, Dumontet C, Martinet L, Leclair S, Xu W, Paiva B, Klein C, Umana P. Forimtamig, a novel GPRC5D-targeting T-cell bispecific antibody with a 2+1 format, for the treatment of multiple myeloma. Blood. 2025 Jan 9;145(2):202-219. doi: 10.1182/blood.2024025987.
PubMed 39476124
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig (RO7425781) in Participants With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04557150
- Acronym / sponsor ID
- BP42233
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 21 Sep 2020 (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 is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. Forimtamig will be administered to participants with r/r MM for whom no standard-of-care treatment exists or who are intolerant to those established therapies. The study consists of two parts: dose-escalation of forimtamig (Part 1) and a randomized dose expansion of forimtamig (Part 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part I: Dose Escalation | Experimental | Drug: ForimtamigParticipants will receive forimtamig as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion. |
| Part II: Dose Expansion | Experimental | Drug: ForimtamigDose Expansion cohorts with IV and/or SC administration, respectively, will be initiated at the Recommended Phase 2 Doses (RP2Ds) determined in Part I: Dose Escalation phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Previously diagnosed with Multiple Myeloma (MM) based on standard criteria.
- Dose Escalation Phase and Dose Expansion Phase: Participants with r/r MM who have previously received therapy with an Immunomodulatory drug (IMiD) and Proteasome Inhibitor (PI) and are intolerant to or have no other option for standard-of-care treatment according to the Investigator.
- Life expectancy of at least 12 weeks.
- Agreement to provide protocol-specific biopsy material.
- AEs from prior anti-cancer therapy resolved to Grade =<1.
Key exclusion criteria (10 listed)
- Inability to comply with protocol-mandated hospitalization and activities restrictions.
- Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after last dose of study drug.
- Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for MM treatment within 2 weeks before first forimtamig administration.
- Prior treatment with systemic immunotherapeutic agents within 2 weeks before first forimtamig administration.
- Treatment-related, immune-mediated AEs associated with prior immunotherapeutic agents.
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 |
|---|---|---|
| ForimtamigAlso: RO7425781Forimtamig will be administered via IV/SC administration. The RP2Ds determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. Forimtamig will be administered as per the dosing schedule defined in Part I. | Drug | Part I: Dose Escalation, Part II: Dose Expansion |
Primary outcome
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to 104 weeks
Percentage of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 Day 1 up to Cycle 1 Day 35
12 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 104 weeks
Duration of Response (DOR)
Time frame: Up to 104 weeks
Progression-Free Survival (PFS)
Time frame: Up to 104 weeks
Overall Survival (OS)
Time frame: Up to 104 weeks
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig
Time frame: Up to 104 weeks
Maximum Concentration (Cmax) of Forimtamig
Time frame: Up to 104 weeks
Time of Maximum Concentration (Tmax) of Forimtamig
Time frame: Up to 104 weeks
Minimum Concentration (Cmin) of Forimtamig
Time frame: Up to 104 weeks
SC Bioavailability (F) of Forimtamig
Time frame: Up to 104 weeks
Apparent Clearance (CL/F) of Forimtamig
Time frame: Up to 104 weeks
Volume of Distribution at Steady State (Vss) of Forimtamig (IV only)
Time frame: Up to 104 weeks
Area Under the Curve (AUC) at Various Time Intervals of Forimtamig
Time frame: Up to 104 weeks
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 13 Apr 2026.
- Derived from this study: PubMed 42310437Kraft TE, Marrer-Berger E, Belli S, Haegel H, Schneider A, Giusti AM, Bscheider M, Jacob W, Weisser M, Blanco L, Frances N, Rossmann E, Steiner G, Azpiroz AZ, Paiva B, Martinet L, Fauti T. Patient-Centric First-in-Human Dose Selection: An Ex Vivo Minimal Anticipated Biological Effect Level Approach for T-Cell Engagers in Multiple Myeloma. Clin Pharmacol Ther. 2026 Sep;120(3):745-752. doi: 10.1002/cpt.70366. Epub 2026 Jun 17.
- Derived from this study: PubMed 39476124Eckmann J, Fauti T, Biehl M, Zabaleta A, Blanco L, Lelios I, Gottwald S, Rae R, Lechner S, Bayer C, Dekempe Q, Osl F, Carrie N, Kassem S, Lorenz S, Christopeit T, Carpy A, Bujotzek A, Broske AM, Dekhtiarenko I, Attig J, Kunz L, Cremasco F, Adelfio R, Fertig G, Dengl S, Gassner C, Bormann F, Kirstenpfad C, Kraft T, Diggelmann S, Knobloch M, Hage C, Feddersen R, Heidkamp G, Poschinger T, Mayoux M, Bernasconi L, Prosper F, Dumontet C, Martinet L, Leclair S, Xu W, Paiva B, Klein C, Umana P. Forimtamig, a novel GPRC5D-targeting T-cell bispecific antibody with a 2+1 format, for the treatment of multiple myeloma. Blood. 2025 Jan 9;145(2):202-219. doi: 10.1182/blood.2024025987.
- 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
20 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Forimtamig in people with Multiple Myeloma, run by Hoffmann-La Roche at 20 sites in 9 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 8 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy, France, South Korea, Spain, Denmark and 4 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?
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 104 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04557150, which also lists 2 linked publications.
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 13 Apr 2026.