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OMP-18R5

Phase 1

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

OMP-18R5 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Apr 2011

OMP-18R5 target and mechanism

ModalityMonoclonal antibody

Also known as Vantictumab

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment99

FDA Designations

No designations recorded

OMP-18R5 clinical trials

OMP-18R5 · 3 trials · 3 indications

Phase 1 3
NCT01957007A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLCSolid Tumors
COMPLETED34 Analytics
NCT02005315A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic CancerPancreatic Cancer
COMPLETED30 Analytics
NCT01345201A Dose Escalation Study of OMP-18R5 in Subjects With Solid TumorsSolid Tumors
COMPLETED35 Analytics
PHASE1COMPLETED
A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC
Solid TumorsUnlock trial analytics
PHASE1COMPLETED
A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer
Pancreatic CancerUnlock trial analytics
PHASE1COMPLETED
A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of vantictumab in combination with docetaxel in patients with recurrent or advanced NSCLC. The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly paclitaxel.
Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)
Phase 1b: Safety and tolerability of vantictumab 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 (Days 0-28)

The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly nab-paclitaxel

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

Pharmacokinetics (PK) of vantictumab when administered in combination with docetaxel to patients with recurrent or advanced NSCLC
Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the vantictumab infusion and before docetaxel infusion from Day 0 to treatment termination
Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer
Vantictumab will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle.
To determine the pharmacokinetics of OMP-18R5 in subjects with previously treated solid tumors
The first 8 weekly doses and following treatment termination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DocetaxelEXPERIMENTALDrug: Docetaxel - administered intravenously
vantictumabEXPERIMENTALDrug: vantictumab - administered intravenously
Vanctictumab (OMP-18R5)EXPERIMENTALVantictumab will be administered by intravenous (IV) infusion.
Nab-PaclitaxelEXPERIMENTALNab-Paclitaxel will be administered by intravenous (IV) infusion.
GemcitabineEXPERIMENTALGemcitabine will be administered by intravenous (IV) infusion.

Interventions

NameTypeDescription
DocetaxelDRUGDocetaxel will be administered IV.
vantictumabDRUGVantictumab will be administered intravenously
Nab-PaclitaxelDRUGNab-Paclitaxel will be administered by intravenous (IV) infusion.
GemcitabineDRUGGemcitabine will be administered by intravenous (IV) infusion.
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: * Signed Informed Consent Form * Age ≥18 years * Histologically documented recurrent or advanced (Stage IV) NSCLC * Eastern CooperativeOncology Group (ECOG) performance status of 0 or 1 * All acute treatmentrelated toxicity from prior therapy must have resolved to Grade ≤ 1 prio...

Countries:United States
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumors")

Frequently asked questions about OMP-18R5

What is OMP-18R5 used for?

OMP-18R5 is an investigational monoclonal antibody being studied for the treatment of solid tumors. It was evaluated in a Phase 1 dose escalation study in adults with solid tumors. It is not approved for any indication and remains in clinical development.

Who is developing OMP-18R5?

OMP-18R5 is being developed by Mereo BioPharma Group plc, which trades under the ticker MREO. The company is the sponsor of the clinical program for this monoclonal antibody in oncology.

What phase is OMP-18R5 in?

OMP-18R5 is in Phase 1 clinical development. It has completed one Phase 1 trial in patients with solid tumors. The drug is investigational and has not been approved by the FDA for any use.

What clinical trials is OMP-18R5 in?

OMP-18R5 has been studied in one clinical trial, NCT01345201, titled A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors. The Phase 1 trial enrolled 35 participants in the United States and is now completed.

Is OMP-18R5 FDA approved?

No, OMP-18R5 is not FDA approved. It is an investigational monoclonal antibody that has completed a single Phase 1 dose escalation trial in solid tumors. Further clinical development would be required before any regulatory approval could be considered.