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RO7297089

Phase 1

Refractory Multiple Myeloma | Small molecule | Oncology |Roche Holding AG|Last Updated: Jul 3, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

RO7297089 · 1 trial · 2 indications

Phase 1 1
NCT04434469A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple MyelomaRefractory Multiple Myeloma
COMPLETED27 Analytics
PHASE1COMPLETED
A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
Refractory Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Time to Maximum Concentration Observed (Tmax) of RO7297089
Cycle 1 Day 1
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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A Flat Dose Escalation: RO7297089EXPERIMENTALParticipants 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: RO7297089EXPERIMENTALParticipants 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: RO7297089EXPERIMENTALNo 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.
Phase I Expansion Stage: RO7297089EXPERIMENTALNo 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.

Interventions

NameTypeDescription
RO7297089DRUGRO7297089 will be given via intravenous (IV) infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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: ...

Countries:AustraliaBelgiumDenmarkNorway
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Competitive Landscape -Multiple Myeloma 221 trials (matched to "Refractory Multiple Myeloma")

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about RO7297089

What is RO7297089 used for?

RO7297089 is an investigational small molecule being developed for the treatment of refractory multiple myeloma. It is also being studied in patients with relapsed multiple myeloma. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes RO7297089?

RO7297089 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug in patients with relapsed or refractory multiple myeloma.

What phase is RO7297089 in?

RO7297089 is in Phase 1 clinical development. A Phase 1 study evaluating escalating doses of the drug in patients with relapsed or refractory multiple myeloma has been completed. The drug is investigational and has not received regulatory approval.

What clinical trials is RO7297089 in?

RO7297089 has one completed clinical trial, identified as NCT04434469. This Phase 1 study evaluated the safety and pharmacokinetics of escalating doses of RO7297089 in patients with relapsed or refractory multiple myeloma. The trial enrolled 27 participants across Australia, Belgium, Denmark, and Norway.

Is RO7297089 FDA approved?

RO7297089 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of refractory and relapsed multiple myeloma. The completed Phase 1 trial focused on safety and pharmacokinetics, and further studies would be needed for regulatory approval.