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OMP-54F28, Nab-Paclitaxel and Gemcitabine

Phase 1

Pancreatic Cancer | Small molecule | 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 Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

OMP-54F28, Nab-Paclitaxel and Gemcitabine · 1 trial · 2 indications

Phase 1 1
NCT02050178Dose Escalation Study of OMP-54F28 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic CancerPancreatic Cancer
COMPLETED26 Analytics
PHASE1COMPLETED
Dose Escalation Study of OMP-54F28 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer
Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of OMP-54F28 in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer
Subjects will be treated and observed for DLT through the end of the first cycle (from Day 0 - 28)

The maximum tolerated dose (MTD) will be determined in patients treated with gemcitabine in combination with weekly nab-paclitaxel (from Day 0 - 28)

Secondary Endpoints

Pharmacokinetics (PK) of OMP-54F28 when administered in combination with nabpaclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer
Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the gemcitabine infusion and before nabpaclitaxel infusion from Day 0 to treatment termination
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Drug: OMP-54F28, Nab-Paclitaxel and GemcitabineEXPERIMENTAL -

Interventions

NameTypeDescription
OMP-54F28, Nab-Paclitaxel and GemcitabineDRUG -
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Signed Informed Consent Form * Age ≥18 years * Histologically documented Stage IV ductal adenocarcinoma of the pancreas * Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy * Tumor tissue from fine needle aspiration is not accept...

Countries:United States
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Competitive Landscape -Pancreatic Cancer 179 trials

Top 20 of 68 competitors

CompanyTickerTrialsLead PhaseDrugs
Revolution Medicines, Inc.RVMD9PHASE3RMC-6236, Gemcitabine, nab-paclitaxel, Irinotecan, Liposomal irinotecan
Arcus Biosciences, Inc.RCUS3PHASE3Quemliclustat, Nab-paclitaxel, Gemcitabine
Pfizer Inc.PFE7PHASE2tisotumab vedotin, pembrolizumab, carboplatin, cisplatin
AstraZeneca PLCAZN9PHASE2AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan
AbbVie, Inc.ABBV4PHASE2TTX-030, nab-paclitaxel and gemcitabine, Nab-Paclitaxel and gemcitabine
AngioDynamics, Inc.ANGO2PHASE3Modified FOLFIRINOX Regimen
Bristol-Myers Squibb CompanyBMY4PHASE2Navlimetostat, Gemcitabine, Nab-paclitaxel
Immuneering Corp. Class AIMRX2PHASE3Atebimetinib, GnP, mGnP
RenovoRx, Inc.RNXT1PHASE3Gemcitabine, nab-paclitaxel
BioNTech SE Sponsored ADRBNTX2PHASE2Pumitamig, Nab-paclitaxel, Gemcitabine, mFOLFIRINOX
Veracyte, Inc.VCYT1PHASE3Tislelizumab
ArriVent BioPharma, Inc.AVBP3PHASE2JAB-21822
Merck & Co., Inc.MRK2PHASE2Belzutifan
Eli Lilly and CompanyLLY7PHASE1LY4101174
Exelixis, Inc.EXEL1PHASE2Zanzalintinib, Everolimus
Agenus Inc.AGEN4PHASE2AGEN1423, Botensilimab, Gemcitabine, Nab-paclitaxel
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE2Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine, Surufatinib with Nab-paclitaxel, and Gemcitabine
Incyte CorporationINCY3PHASE2Ruxolitinib, Capecitabine, Regorafenib
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE2Zanidatamab
ImmunityBio IncIBRX1PHASE2N-803, Aldoxorubicin, PD-L1 t-haNK, Nab-paclitaxel, Gemcitabine
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Frequently asked questions about OMP-54F28, Nab-Paclitaxel and Gemcitabine

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.