Clinical trial NCT06055075: A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Relapsed or Refractory Multiple Myeloma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-09-26
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 24 months
measure: Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria
timeFrame: Up to approximately 24 months
measure: Complete Response (CR)/Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria
timeFrame: Up to approximately 24 months
measure: Rate of Very Good Partial Response (VGPR) or Better as Determined by the Investigator per IMWG Criteria
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Progression-Free Survival (PFS) as Determined by the Investigator per IMWG Criteria
timeFrame: Up to approximately 24 months
measure: Duration of Response (DoR) for Participants who Achieve a Partial Response (PR) or Better as Determined by the Investigator per IMWG Criteria
timeFrame: Up to approximately 24 months
measure: Time to First Response as Determined by the Investigator per IMWG Criteria
timeFrame: Up to approximately 24 months
measure: Time to Best Response as Determined by the Investigator per IMWG Criteria
timeFrame: Up to approximately 24 months
measure: Overall Survival (OS) as Determined by the Investigator per IMWG Criteria
timeFrame: Up to approximately 24 months
measure: Serum Concentration of Forimtamig
timeFrame: Up to approximately 24 months
measure: Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital Woolloongabba
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research - Auckland
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: