A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

Study Purpose

The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r MM). The study consists of two phases: a dose exploration phase and a dose-expansion phase.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

- Life expectancy of at least 12 weeks.

- Documented diagnosis of MM according to the IMWG diagnostic criteria.

- Evidence of progressive disease based on Investigator's determination of response by IMWG criteria on or after last dosing regimen.

- Measurable disease.

- AEs from prior anti-cancer therapy resolved to Grade ≤ 1, - Adequate organ functions.

Exclusion Criteria:

- Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the last dose of study drug.

- Plasma cell leukemia with circulating plasma cell count ≥ 5% or >500/microliter (µL) - Participants with known amyloidosis.

- Participants with myelodysplastic syndrome.

- Prior treatment with monoclonal antibody (mAb) and antibody-drug conjugate within 4 weeks or 5 half-lives of the drug, whichever is shorter.

- Prior anti-cancer therapy (chemotherapy, small molecule/tyrosine kinase inhibitors, radiotherapy) within 14 days prior to first forimtamig administration.

- Prior solid organ transplantation.

- Active auto-immune disease or flare within 6 months prior to start of study treatment.

- Known or suspected chronic active Epstein-Barr virus (EBV) infection.

- Hepatitis B virus (HBV) infection.

- Acute or chronic hepatitis C virus (HCV) infection.

- Known history of HIV seropositivity.

- Live vaccine(s) within one month prior to start of the treatment.

- Participants not fully vaccinated for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as per local recommendations.

- Previous refractoriness to carfilzomib.

- Participants who discontinued prior carfilzomib treatment due to treatment-related toxicity.

- Participants with known liver cirrhosis.

- Participants eligible for allogeneic stem cell transplantation (SCT) or autologous SCT at the time of enrollment for Study BP43437 are excluded

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06055075
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hoffmann-La Roche
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trials
Principal Investigator Affiliation	Hoffmann-La Roche
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Canada, Denmark, France, Italy, Korea, Republic of, New Zealand, Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsed or Refractory Multiple Myeloma

Arms & Interventions

Arms

Experimental: Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib

Participants will receive Dose 1 of forimtamig, subcutaneous (SC) injection in combination with carfilzomib, intravenous (IV) infusion until disease progression.

Experimental: Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib

Participants will receive Dose 2 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.

Experimental: Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib

Participants will receive Dose 3 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.

Experimental: Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab

Participants will receive Dose 1 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.

Experimental: Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab

Participants will receive Dose 2 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.

Experimental: Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab

Participants will receive Dose 3 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.

Experimental: Dose Expansion Phase: Forimtamig

Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase until disease progression or completion of 12 months of treatment, whichever occurs first.

Experimental: Dose Expansion Phase: Forimtamig + Carfilzomib

Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with carfilzomib, IV infusion until disease progression.

Experimental: Dose Expansion Phase: Forimtamig + Daratumumab

Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with daratumumab, SC injection until disease progression.

Interventions

Drug: - Forimtamig

Forimtamig will be administered SC at different doses during dose exploration phase. Forimtamig will be administered at a fixed dose determined during dose exploration phase in dose expansion phase.

Drug: - Carfilzomib

Carfilzomib will be administered via IV infusion in combination with forimtamig.

Drug: - Daratumumab

Daratumumab will be administered via SC injection in combination with forimtamig.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Woolloongabba, Queensland, Australia

Status

Recruiting

Address

Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

Woolloongabba, Queensland, 4102

Site Contact

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