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OMP-18R5

Phase 1

Solid Tumors | Monoclonal antibody | Oncology |Mereo BioPharma Group plc|Last Updated: Sep 9, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

OMP-18R5 · 1 trial · 1 indication

Phase 1 1
NCT01345201A Dose Escalation Study of OMP-18R5 in Subjects With Solid TumorsSolid Tumors
COMPLETED35 Analytics
PHASE1COMPLETED
A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors
Solid Tumors
NCT0134520135
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Study Endpoints

Primary Endpoints

To determine the safety of OMP-18R5 in subjects with previously treated solid tumors
Subjects will be assessed for dose limiting toxicity from Days 0-28. Adverse events will be reported through 30 days after the last dose.

Secondary Endpoints

To determine the pharmacokinetics of OMP-18R5 in subjects with previously treated solid tumors
The first 8 weekly doses and following treatment termination
To determine the immunogenicity of OMP-18R5 in subjects with previously treated solid tumors
Subjects will be assessed during screening, every 4 weeks, treatment termination, weekly for the first 4 weeks following d/c of study drug, Weeks 8 and 12 following d/c of drug.
To assess the preliminary efficacy of OMP-18R5 in subjects with previously treated solid tumors
Every 56 days until disease progression
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
OMP-18R5BIOLOGICALIV infusion. Subjects with stable disease or a response at Day 56 will be allowed to continue until disease progression.
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Subjects must have a histologically confirmed malignancy that is metastatic or unresectable for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. In addition, subjects must have a tumor that is at least 1 cm in a single...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about OMP-18R5

What is OMP-18R5 used for?

OMP-18R5 is an investigational monoclonal antibody being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development and has been studied in a dose escalation trial involving patients with solid tumors. The drug is not yet approved and remains under clinical investigation.

Who makes OMP-18R5?

OMP-18R5 is being developed by Mereo BioPharma Group plc, a biopharmaceutical company listed on the stock exchange under the ticker MREO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody for the treatment of solid tumors.

What phase is OMP-18R5 in?

OMP-18R5 is in Phase 1 clinical development. A Phase 1 dose escalation study has been completed, involving 35 patients with solid tumors. The drug is investigational and has not received regulatory approval for any indication.

What clinical trials is OMP-18R5 in?

OMP-18R5 has been studied in one clinical trial, identified as NCT01345201, titled "A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors." This Phase 1 trial was completed in the United States and enrolled 35 adult patients with solid tumors. The trial was uncontrolled and not randomized or blinded.

What does OMP-18R5 target?

OMP-18R5 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential role in treating solid tumors, though the exact mechanism of action has not been publicly detailed.