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OMP-54F28

Phase 1

Solid Tumors | Monoclonal antibody | Oncology |Mereo BioPharma Group plc|Last Updated: Aug 11, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

OMP-54F28 · 1 trial · 1 indication

Phase 1 1
NCT01608867A Dose Escalation Study of OMP-54F28 in Subjects With Solid TumorsSolid Tumors
COMPLETED26 Analytics
PHASE1COMPLETED
A Dose Escalation Study of OMP-54F28 in Subjects With Solid Tumors
Solid Tumors
NCT0160886726
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Study Endpoints

Primary Endpoints

• To determine the safety of OMP-54F28 in subjects with previously treated solid tumors
Subjects will be assessed for dose limiting toxicities from Days 0-28. Adverse events will be reported through 30 days after the last dose.

Secondary Endpoints

To determine the pharmacokinetics of OMP-54F28 in subjects with previously treated solid tumors
Baseline,end of infusion,0.5,1,3,6,24, and 72 hours post-infusion (1st infusion) 0.5, 1, 3, 6, 24, 72, and 168 hours (3rd infusion),before/end 2nd infusion,Days 7, 14, 28, and 35. After termination: Weekly for the first 4 weeks, then at Week 8 and 12
To determine the immunogenicity of OMP-54F28 in subjects with previously treated solid tumors
Subjects will be assessed during screening ,every 4 weeks while on study drug, at the time of treatment termination, then weekly for the first 4 weeks, then at Week 8 and 12 following discontinuation of study drug
To assess the preliminary efficacy of OMP-54F28 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-54F28BIOLOGICALdose escalation of 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for the study: 1. Subjects must have a histologically confirmed malignancy that is metastatic or unresectable and must have received the standard therapies for their malignancy. In addition, subjects must have a tu...

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-54F28

What is OMP-54F28 used for?

OMP-54F28 is an investigational monoclonal antibody being studied for the treatment of solid tumors, including pancreatic cancer, ovarian cancer, and hepatocellular cancer. It is in Phase 1 clinical development and is not yet approved by the FDA.

What does OMP-54F28 target?

OMP-54F28 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. It is being evaluated in oncology for its potential to treat various solid tumors.

Who makes OMP-54F28?

OMP-54F28 is being developed by Mereo BioPharma Group plc, a biopharmaceutical company listed on the stock exchange under the ticker MREO.

What phase is OMP-54F28 in?

OMP-54F28 is in Phase 1 clinical development. It has completed four Phase 1 trials, and no active trials are currently listed. It remains investigational and has not received FDA approval.

What clinical trials is OMP-54F28 in?

OMP-54F28 has completed four Phase 1 trials: NCT01608867 in solid tumors, NCT02050178 in pancreatic cancer, NCT02069145 in hepatocellular cancer, and NCT02092363 in ovarian cancer. All trials were completed in the United States.

Is OMP-54F28 the same as other drugs?

OMP-54F28 is not known to have alternative names. It is a distinct investigational monoclonal antibody being developed by Mereo BioPharma for multiple oncology indications.