Recent Updates
Recently added Catalysts

OMP-131R10

Phase 1

Advanced Relapsed Tumors | Small molecule | Oncology |Mereo BioPharma Group plc|Last Updated: Aug 11, 2020

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

OMP-131R10 · 1 trial · 2 indications

Phase 1 1
NCT02482441A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10Advanced Relapsed Tumors
COMPLETED50 Analytics
PHASE1COMPLETED
A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10
Advanced Relapsed TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of dose limiting toxicities (DLTs)
DLTs during the evaluation (28 days)

Subject will be assessed for DLTs during the evaluation window (28 days). Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined.

Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OMP-131R10 intravenous (in the vein) infusionsEXPERIMENTALOMP-131R10 will be administered IV on the first day of each 14-day cycle.
FOLFIRI (5-FU, irinotecan, leucovorin).EXPERIMENTALdosing continues up to the 20 mg/kg dose level

Interventions

NameTypeDescription
OMP-131R10DRUGThere are 5 planned dose cohorts of OMP-131R10. Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity.
FOLFIRIDRUGTreatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for the study: 1. Phase 1a portion: Histologically confirmed advanced relapsed or refractory solid tumors that have exhausted standard of care therapy or either refuse or are not considered to be candidates for any...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about OMP-131R10

What is OMP-131R10 used for?

OMP-131R10 is an investigational small molecule being developed for the treatment of advanced relapsed tumors and refractory solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does OMP-131R10 target?

The specific molecular target of OMP-131R10 has not been disclosed in available information. The drug is being studied for its safety, pharmacokinetics, and pharmacodynamics in patients with advanced relapsed tumors.

Who makes OMP-131R10?

OMP-131R10 is being developed by Mereo BioPharma Group plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol MREO.

What phase is OMP-131R10 in?

OMP-131R10 is in Phase 1 clinical development. A Phase 1a/b dose escalation study has been completed, but the drug remains investigational and is not yet approved for any use.

What clinical trials is OMP-131R10 in?

OMP-131R10 has one completed clinical trial, identified as NCT02482441, which was a Phase 1a/b dose escalation study evaluating the safety, pharmacokinetics, and pharmacodynamics of the drug in patients with advanced relapsed tumors and refractory solid tumors.

Is OMP-131R10 the same as any other drug?

No alternative names for OMP-131R10 have been reported. The drug is known only by its investigational identifier OMP-131R10.