Recent Updates
Recently added Catalysts

OMP-54F28 with Sorafenib

Phase 1

Hepatocellular Cancer | Small molecule | Oncology |Mereo BioPharma Group plc|Last Updated: Aug 11, 2020

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

OMP-54F28 with Sorafenib · 1 trial · 2 indications

Phase 1 1
NCT02069145Dose Escalation Study of OMP-54F28 in Combination With Sorafenib in Patients With Hepatocellular CancerHepatocellular Cancer
COMPLETED10 Analytics
PHASE1COMPLETED
Dose Escalation Study of OMP-54F28 in Combination With Sorafenib in Patients With Hepatocellular Cancer
Hepatocellular CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of OMP-54F28 in combination with sorafenib in patients with hepatocellular cancer
Subjects will be treated and observed for DLT through the end of the first cycle (from Day 0 - 21)

The maximum tolerated dose (MTD) will be determined in patients treated with OMP-54F28 in combination with sorafenib in patients with hepatocellular cancer

Secondary Endpoints

Pharmacokinetics (PK) of OMP-54F28 and sorafenib when administered in combination to patients with hepatocellular cancer
OMP-54F28 will be administered IV on Day 1 of each 21 day cycle. Plasma sample for Parmacokinetics (PK) analysis to be obtained at various time points, 30 minutes after end of OMP-54F28 infusion and before sorafenib treatment
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Drug: OMP-54F28, with SorafenibEXPERIMENTAL -

Interventions

NameTypeDescription
OMP-54F28 with SorafenibDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Signed Informed Consent Form * Age ≥18 years * Histologically documented hepatocellular carcinoma * Locally advanced or metastatic disease * Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy o Tumor tissue from fine needle as...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about OMP-54F28 with Sorafenib

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.