A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04557150
• Other study ID #: BP42233
• Secondary ID: 2020-002012-4620
• Status: Recruiting
• Phase: Phase 1
• Start date: November 11, 2020
• Est. completion date: August 15, 2026

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: BP42233 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. and Canada)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The study consists of two parts: dose-escalation of forimtamig (Part 1) and a randomized dose expansion of forimtamig (Part 2).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: August 15, 2026
• Est. primary completion date: August 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Forimtamig
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.

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Center	North Melbourne	Victoria
Belgium	UZ Gent	Gent
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
France	Hopital De Haut Leveque; Hematologie Clinique	Pessac
Italy	Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli"	Bologna	Emilia-Romagna
Italy	Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia	Milano	Lombardia
Italy	IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica	Napoli	Campania
Italy	Instituto Clinico Humanitas; Med Onc & Hemat	Rozzano	Lombardia
Korea, Republic of	Asan Medical Center	Seoul
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 Universitaria de Navarra; Servicio de Hematologia	Pamplona	Navarra
Spain	Hospital Clinico Universitario de Salamanca;Servicio de Hematologia	Salamanca
Spain	Hospital Universitario Marques de Valdecilla; Servicio de Hematologia	Santander	Cantabria
United Kingdom	St James University Hospital; Institute of Oncology	Leeds
United Kingdom	University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility	London

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Belgium,  Denmark,  France,  Italy,  Korea, Republic of,  New Zealand,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events (AEs)		Up to 104 weeks
Primary	Percentage of Participants with Dose Limiting Toxicities (DLTs)		Cycle 1 Day 1 up to Cycle 1 Day 35
Secondary	Objective Response Rate (ORR)		Up to 104 weeks
Secondary	Duration of Response (DOR)		Up to 104 weeks
Secondary	Progression-Free Survival (PFS)		Up to 104 weeks
Secondary	Overall Survival (OS)		Up to 104 weeks
Secondary	Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig		Up to 104 weeks
Secondary	Maximum Concentration (Cmax) of Forimtamig		Up to 104 weeks
Secondary	Time of Maximum Concentration (Tmax) of Forimtamig		Up to 104 weeks
Secondary	Minimum Concentration (Cmin) of Forimtamig		Up to 104 weeks
Secondary	SC Bioavailability (F) of Forimtamig		Up to 104 weeks
Secondary	Apparent Clearance (CL/F) of Forimtamig		Up to 104 weeks
Secondary	Volume of Distribution at Steady State (Vss) of Forimtamig (IV only)		Up to 104 weeks
Secondary	Area Under the Curve (AUC) at Various Time Intervals of Forimtamig		Up to 104 weeks