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OMP-52M51

Phase 1

Relapsed or Refractory Lymphoid Malignancies | Small molecule | Other |Mereo BioPharma Group plc|Trials Updated: Sep 9, 2020

OMP-52M51 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Oct 2012

OMP-52M51 target and mechanism

ModalitySmall molecule

Also known as brontictuzumab

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment79

FDA Designations

No designations recorded

OMP-52M51 clinical trials

OMP-52M51 · 3 trials · 3 indications

Phase 1 3
NCT03031691A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal CancerMetastatic Colorectal Cancer
COMPLETED7 Analytics
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 Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
Metastatic Colorectal CancerUnlock trial 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

Percentage of patients with adverse events
up to approximately 2 years
Percentage of patients with dose limiting toxicities
28 days
Percentage of patients with anti-brontictuzumab antibodies
up to approximately 2 years
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

Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
approximately 2 years
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1
approximately 2 years
Changes in number of circulating tumor cells
approximately 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Brontictuzumab and trifluridine/tipiracilEXPERIMENTALBrontictuzumab will be administered per protocol and trifluridine/tipiracil per label.
OMP-52M51EXPERIMENTAL -

Interventions

NameTypeDescription
brontictuzumabDRUGstarting dose of 1.5mg/kg administered intravenously (IV)
trifluridine/tipiracilDRUG -
OMP-52M51DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Histologically confirmed metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if KRAS wild-type, an anti-EGFR therapy * ECOG performance status 0 or 1 Exclusion Crit...

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

What is OMP-52M51?

OMP-52M51 is an investigational small molecule being developed by Mereo BioPharma Group plc for relapsed or refractory lymphoid malignancies and relapsed or refractory solid tumors. It has been studied in Phase 1 dose escalation trials in adults aged 18 years and older in the United States.

What is OMP-52M51 used for?

OMP-52M51 has been studied in relapsed or refractory lymphoid malignancies and relapsed or refractory solid tumors. Both are cancer indications in patients whose disease has returned or has not responded to prior treatment. It remains investigational and is not an approved therapy for these or any other conditions.

Who is developing OMP-52M51?

Mereo BioPharma Group plc is developing OMP-52M51. The company trades on the Nasdaq under the ticker MREO. Mereo BioPharma holds the development program for this small molecule asset across its studied cancer indications.

What phase is OMP-52M51 in?

OMP-52M51 is in Phase 1 development. Its clinical program consists of completed Phase 1 dose escalation studies, and no later-phase trials have been recorded. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is OMP-52M51 in?

OMP-52M51 has been evaluated in two completed Phase 1 dose escalation studies. NCT01778439 enrolled 48 participants with relapsed or refractory solid tumors, and NCT01703572 enrolled 24 participants with relapsed or refractory lymphoid malignancies. Both trials were conducted in the United States in adults aged 18 years and older.

How many patients were enrolled in OMP-52M51 trials?

The OMP-52M51 clinical program enrolled 48 participants in the solid tumor study NCT01778439 and 24 participants in the lymphoid malignancy study NCT01703572. Both were Phase 1 dose escalation trials, were uncontrolled, and were not randomized or double blinded.