Clinical trial NCT04434469: A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
Official title: An Open-Label, Multicenter, Phase I Trial Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Refractory Multiple Myeloma
Relapsed Multiple Myeloma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a first-in-human Phase I, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089 and make a preliminary assessment of anti-tumor activity in patients with R/R MM for whom no established therapy for MM is appropriate and available or who are intolerant to those established therapies.


Eligibility criteria: Inclusion Criteria

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of at least 12 weeks
* R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
* Measurable disease

Exclusion criteria:

* Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for the treatment of cancer within 4 weeks before first RO7297089 infusion
* Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first RO7297089 infusion
* Prior treatment with CAR-T therapy within 90 days before first study drug administration
* Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first RO7297089 infusion
* Autologous stem cell transplantation within 100 days prior to first RO7297089 infusion
* Allogeneic stem cell transplantation within 180 days prior to first RO7297089 infusion or requiring immunosuppression for treatment or prophylaxis of graft versus host disease
* Primary or secondary plasma cell leukemia
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring treatment with IV anti-microbial therapy within 14 days prior to first RO7297089 infusion
* Significant cardiovascular disease
* Current CNS involvement by MM

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)
timeFrame: Baseline up to 1 year 7 months
Secondary outcomes:
measure: Time to Maximum Concentration Observed (Tmax) of RO7297089
timeFrame: Cycle 1 Day 1
measure: Area Under the Curve (AUC) of RO7297089
timeFrame: Cycle 1 Day 1
measure: Maximum Concentration Observed (Cmax) of RO7297089
timeFrame: Cycle 1 Day 1, Cycle 2 Day 8
measure: Minimum Concentration Observed (Cmin) of RO7297089
timeFrame: Cycle 1 Day 1, Cycle 2 Day 8
measure: Half-life (t1/2) of RO7297089
timeFrame: Cycle 1 Day 1
measure: Objective Response Rate (ORR)
timeFrame: Baseline up to approximately 19 months
Other outcomes:
Locations:
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: LIVERPOOL HOSPITAL; HAEMATOLOGY; Ingham Institute for Medical Research
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital; Haematology Clinical Trials
state: South Australia
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital Melbourne
state: South Australia
city: East Melbourne
country: Australia
facility: Peter Mac Callum Cancer Center
state: Victoria
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: København Ø
country: Denmark
facility: Rigshospitalet
city: Vejle
country: Denmark
facility: Vejle Sygehus; Onkologisk Afdeling
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF; Ullevål sykehus
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: