A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma

Refractory Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04434469
• Other study ID #: GO41582
• Status: Completed
• Phase: Phase 1
• Start date: July 8, 2020
• Est. completion date: February 16, 2022

Study information

• Verified date: June 2022
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 16, 2022
• Est. primary completion date: February 16, 2022
• 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

• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• RO7297089
RO7297089 will be given via intravenous (IV) infusion

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital; Haematology Clinical Trials	Adelaide	South Australia
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Peter Mac Callum Cancer Center	East Melbourne	Victoria
Australia	St. Vincent's Hospital Melbourne	Fitzroy	South Australia
Australia	LIVERPOOL HOSPITAL; HAEMATOLOGY; Ingham Institute for Medical Research	Liverpool	New South Wales
Belgium	UZ Gent	Gent
Belgium	UZ Leuven	Leuven
Denmark	Rigshospitalet	København Ø
Denmark	Vejle Sygehus; Onkologisk Afdeling	Vejle
Norway	Oslo Universitetssykehus HF; Ullevål sykehus	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

Australia,  Belgium,  Denmark,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with Adverse Events (AEs), including Dose Limiting Toxicities (DLTs)	Adverse event severity will be graded according to NCI CTCAE v5.0	Baseline up to approximately 3 years
Secondary	Serum Concentration of RO7297089	Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit	Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary	Area under the Curve (AUC) of RO7297089	Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit	Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary	Maximum Concentration Observed (Cmax) of RO7297089	Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit	Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary	Time to Maximum Concentration Observed (tmax) of RO7297089	Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit	Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary	Minimum Concentration Observed (Cmin) of RO7297089	Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit	Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary	Volume of Distribution at Steady State of RO7297089	Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit	Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary	Half-life of RO7297089	Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit	Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary	Total clearance of RO7297089	Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit	Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary	Objective Response Rate (ORR)	ORR is defined as a Stringent Complete Response (Scr), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) as determined by the Investigator according to International Myeloma Working Group (IMWG) Uniform Response Criteria	Baseline up to approximately 3 years
Secondary	Duration Of Response (DOR)	DOR is defined as the time from the first occurrence of a documented Objective Response to Disease Progression or death from any cause (whichever occurs first), as determined by the Investigator according to IMWG Uniform Response Criteria	Baseline up to approximately 3 years
Secondary	Prevalence Of Anti-Drug Antibodies (ADAs)	Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit	Baseline up to approximately 3 years (detailed time frame provided in description)