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OMP-54F28, Paclitaxel and Carboplatin

Phase 1

Ovarian Cancer | Small molecule | Oncology |Mereo BioPharma Group plc|Last Updated: Aug 12, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

OMP-54F28, Paclitaxel and Carboplatin · 1 trial · 1 indication

Phase 1 1
NCT02092363Dose Escalation Study of OMP-54F28 in Combination With Paclitaxel and Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian CancerOvarian Cancer
COMPLETED37 Analytics
PHASE1COMPLETED
Dose Escalation Study of OMP-54F28 in Combination With Paclitaxel and Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian Cancer
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of OMP-54F28 in combination with paclitaxel and carboplatin in patients with recurrent platinum-sensitive ovarian 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/paclitaxel/carboplatin (from Day 0 - 21)

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Drug: OMP-54F28, Paclitaxel and CarboplatinEXPERIMENTAL -

Interventions

NameTypeDescription
OMP-54F28, Paclitaxel and CarboplatinDRUG -
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Eligibility Criteria

Age Range18 Years to 90 Years
SexFEMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Signed Informed Consent Form * Age ≥18 years * Histologically documented ovarian, primary peritoneal or fallopian tube cancer * Recurrent platinum-sensitive disease, defined as disease progression ≥6 months after completing a minimum of 4 cycles of a platinum-containing regime...

Countries:United States
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Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Frequently asked questions about OMP-54F28, Paclitaxel and Carboplatin

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.