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OMP-52M51

Phase 1

Relapsed or Refractory Lymphoid Malignancies | Small molecule | Other |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 Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

OMP-52M51 · 2 trials · 2 indications

Phase 1 2
NCT01778439A Dose Escalation Study of OMP-52M51 in Subjects With Solid TumorsRelapsed or Refractory Solid Tumors
COMPLETED48 Analytics
NCT01703572A Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid MalignanciesRelapsed or Refractory Lymphoid Malignancies
COMPLETED24 Analytics
PHASE1COMPLETED
A Dose Escalation Study of OMP-52M51 in Subjects With Solid Tumors
Relapsed or Refractory Solid TumorsUnlock trial analytics
PHASE1COMPLETED
A Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid Malignancies
Relapsed or Refractory Lymphoid MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety profile of OMP-52M51 in subjects with relapsed or refractory solid tumors
Subjects will be assessed for DLTs from Days 0-29. Adverse events will be reported through 30 days after the last dose
Safety profile of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
Subjects will be assessed for DLTs from Days 0-29. Adverse events will be reported through 30 days after the last dose

Secondary Endpoints

Pharmacokinetics (PK) of OMP-52M51 in subjects with relapsed or refractory solid tumors
PK analyses at various time points following the 1st and 2nd doses, immediately pre and post-dose for all subsequent doses at treatment term, every 4 weeks after discontinuation of study drug or 12 weeks
Immunogenicity
Assessed at baseline, prior to each dose, at treatment termination and every 4 weeks after the discontinuation of the study drug for 12 weeks.
Preliminary Efficacy
Evaluation for response will be assessed on day 70 of study and every 8 weeks (or 9 weeks for Q3W schedule) thereafter and will be based on RECIST v1.1.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OMP-52M51EXPERIMENTAL -

Interventions

NameTypeDescription
OMP-52M51DRUG -
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for the study: 1. Age \>18 years 2. ECOG performance status \<2 (see Appendix B) 3. Solid tumor malignancy for which there is no remaining standard therapy or either refuse or are not considered to be candidates fo...

Countries:United States
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Frequently asked questions about OMP-52M51

What is OMP-52M51 used for?

OMP-52M51 is an investigational small molecule being studied for the treatment of relapsed or refractory lymphoid malignancies and relapsed or refractory solid tumors. It is currently in Phase 1 clinical development and is not approved by the FDA.

Who makes OMP-52M51?

OMP-52M51 is being developed by Mereo BioPharma Group plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol MREO. The drug is currently in Phase 1 clinical trials for the treatment of certain cancers.

What phase is OMP-52M51 in?

OMP-52M51 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 dose escalation studies have been completed, one in lymphoid malignancies and one in solid tumors.

What clinical trials is OMP-52M51 in?

OMP-52M51 has been studied in two completed Phase 1 clinical trials. NCT01703572 was a dose escalation study in subjects with relapsed or refractory lymphoid malignancies, enrolling 24 participants. NCT01778439 was a dose escalation study in subjects with relapsed or refractory solid tumors, enrolling 48 participants.

Is OMP-52M51 the same as any other drug?

No alternative names for OMP-52M51 have been disclosed. The drug is identified solely by its code name OMP-52M51 in clinical trial registries and is being developed by Mereo BioPharma Group plc.