Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Irinotecan

Antibodies

Antibodies, Monoclonal

Leucovorin

Fluorouracil

Immunoglobulins

OMP-131R10 will be administered IV on the first day of each 14-day cycle.

dosing continues up to the 20 mg/kg dose level

There 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.

OMP-131R10

Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen.

FOLFIRI

This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability, and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with metastatic colorectal cancer.

The Phase 1a portion of the study in subjects with advanced solid tumors will consist of a dose escalation part followed by a dose-expansion cohort. OMP-131R10 will be administered IV on the first day of each 14-day cycle.

Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity.

The Phase 1b portion of the study will be conducted in subjects with metastatic colorectal cancer whose tumors have progressed after at least 1 line of therapy for metastatic disease.

Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen.

A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10

A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10 in Advanced Solid Tumors and in Combination With FOLFIRI for Patients With Previously Treated Metastatic Colorectal Cancer

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10	NCT02482441	Advanced Relaps... Refractory Soli...	OMP-131R10 FOLFIRI	18 Years -	Mereo BioPharma
A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10	NCT02482441	Advanced Relaps... Refractory Soli...	OMP-131R10 FOLFIRI	18 Years -	Mereo BioPharma

Spots Global Cancer Trial Database for advanced solid tumors and in combination