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

Phase 1

Completed

• Conditions: Relapsed Multiple Myeloma; Refractory Multiple Myeloma
• Interventions: Drug: RO7297089

• Registration Number: NCT04434469
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Study Start: 2020-07-08
• Primary Completion: 2022-02-23
• Study Completion: 2022-02-23
• Results First Submitted: 2023-02-23
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Results First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase I Expansion Stage: RO7297089	RO7297089	No participants enrolled. Enrollment for the GO41582 study was stopped in July 2021 due to limited activity as a single agent which did not meet the Sponsor's internal criteria for further clinical development.
Arm A Flat Dose Escalation: RO7297089	RO7297089	Participants in Arm A will receive the target dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Arm B Split Dose Escalation: RO7297089	RO7297089	Participants in Arm B will receive the first target dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose will be administered at subsequent study drug administration visits.
Arm C Step Dose Escalation: RO7297089	RO7297089	No participants enrolled. Enrollment for the GO41582 study was stopped in July 2021 due to limited activity as a single agent which did not meet the Sponsor's internal criteria for further clinical development.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)	Baseline up to 1 year 7 months	Adverse event severity graded according to NCI CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) of RO7297089	Cycle 1 Day 1
Maximum Concentration Observed (Cmax) of RO7297089	Cycle 1 Day 1, Cycle 2 Day 8
Half-life (t1/2) of RO7297089	Cycle 1 Day 1
Objective Response Rate (ORR)	Baseline up to approximately 19 months	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
Time to Maximum Concentration Observed (Tmax) of RO7297089	Cycle 1 Day 1
Minimum Concentration Observed (Cmin) of RO7297089	Cycle 1 Day 1, Cycle 2 Day 8

Trial Locations

Locations (10)

UZ Gent; 🇧🇪 Gent, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Oslo Universitetssykehus HF; Ullevål sykehus; 🇳🇴 Oslo, Norway

Concord Repatriation General Hospital; 🇦🇺 Concord, New South Wales, Australia

St. Vincent's Hospital Melbourne; 🇦🇺 Fitzroy, South Australia, Australia

Peter Mac Callum Cancer Center; 🇦🇺 East Melbourne, Victoria, Australia

Rigshospitalet; 🇩🇰 København Ø, Denmark

Vejle Sygehus; Onkologisk Afdeling; 🇩🇰 Vejle, Denmark

LIVERPOOL HOSPITAL; HAEMATOLOGY; Ingham Institute for Medical Research; 🇦🇺 Liverpool, New South Wales, Australia

Royal Adelaide Hospital; Haematology Clinical Trials; 🇦🇺 Adelaide, South Australia, Australia