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

Relapsed or Refractory Multiple Myeloma Clinical Trial

Official title:

An Open-Label, Randomized Phase IB/II Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06055075
• Other study ID #: BP43437
• Secondary ID: 2023-503689-21-0
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 12, 2023
• Est. completion date: June 10, 2027

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: BP43437 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: June 10, 2027
• Est. primary completion date: June 10, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

Intervention

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.
• Carfilzomib
Carfilzomib will be administered via IV infusion in combination with forimtamig.
• Daratumumab
Daratumumab will be administered via SC injection in combination with forimtamig.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology	Woolloongabba	Queensland
Canada	Hamilton Health Sciences	Hamilton	Ontario
Denmark	Aarhus Universitetshospital Skejby; Blodsygdomme - Klinisk Forsknings Enhed	Aarhus N
Denmark	Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT	København Ø
Denmark	Odense Universitetshospital; Hæmatologisk Afdeling	Odense C
France	CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang	Lille
France	CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique	Nantes
Germany	Klinikum Nürnberg Nord; Klinik für Innere Medizin 5, Schwerpunkt Onkologie / Hämatologie	Nürnberg
Italy	Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli"	Bologna	Emilia-Romagna
Italy	IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica	Napoli	Campania
Italy	Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia	Rozzano	Lombardia
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St Mary's Hospital	Seoul
New Zealand	New Zealand Clinical Research - Auckland	Auckland
Spain	Clinica Universidad de Navarra Madrid; Servicio de Hematología	Madrid
Spain	Clinica Universitaria de Navarra; Servicio de Hematologia	Pamplona	Navarra
Spain	Hospital Universitario Marques de Valdecilla; Servicio de Hematologia	Santander	Cantabria

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Canada,  Denmark,  France,  Germany,  Italy,  Korea, Republic of,  New Zealand,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events (AEs)		Up to approximately 24 months
Primary	Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria		Up to approximately 24 months
Primary	Complete Response (CR)/Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria		Up to approximately 24 months
Primary	Rate of Very Good Partial Response (VGPR) or Better as Determined by the Investigator per IMWG Criteria		Up to approximately 24 months
Secondary	Progression-Free Survival (PFS) as Determined by the Investigator per IMWG Criteria		Up to approximately 24 months
Secondary	Duration of Response (DoR) for Participants who Achieve a Partial Response (PR) or Better as Determined by the Investigator per IMWG Criteria		Up to approximately 24 months
Secondary	Time to First Response as Determined by the Investigator per IMWG Criteria		Up to approximately 24 months
Secondary	Time to Best Response as Determined by the Investigator per IMWG Criteria		Up to approximately 24 months
Secondary	Overall Survival (OS) as Determined by the Investigator per IMWG Criteria		Up to approximately 24 months
Secondary	Serum Concentration of Forimtamig		Up to approximately 24 months
Secondary	Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig		Up to approximately 24 months