Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Participants in Arm A will receive the target dose of RO7297089 as a flat dose at each scheduled study drug administration visit

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.

Participants in Arm C will receive the first cycle of RO7297089 as a single-step dose escalation. The Cycle 1 Day 1 dose will be lower than the target dose. The full target dose will be administered at subsequent study drug administration visits.

After dose escalation has been completed, approximately 30 patients will be enrolled in the expansion stage. Participants will receive RO7297089 at the recommended phase 2 dose (at or below the maximum tolerated dose).

RO7297089 will be given via intravenous (IV) infusion

RO7297089

Clinical Trials

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.

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

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

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

Adverse event severity will be graded according to NCI CTCAE v5.0

Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma	NCT04434469	Refractory Mult... Relapsed Multip...	RO7297089	18 Years -	Genentech, Inc.
A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma	NCT04434469	Refractory Mult... Relapsed Multip...	RO7297089	18 Years -	Genentech, Inc.

Spots Global Cancer Trial Database for ro7297089

Every month we try and update this database with for ro7297089 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ro7297089

Every month we try and update this database with for ro7297089 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ro7297089 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.