A Study of the Safety and Pharmacology of MetMAb (PRO143966), a Monovalent Antagonist Antibody to the Receptor C-Met, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors

Genentech

Status and phase: Completed; Phase 1

Conditions: Solid Cancers

Treatments: Drug: bevacizumab; Drug: MetMAb

Study type: Interventional

Funder types: Industry

Identifiers

NCT01068977

OAM4224g

Details and patient eligibility

About

This is a Phase I, open label, dose-escalation study of MetMAb administered by intravenous (IV) infusion in patients with advanced solid malignancies that are refractory to or for which there is no standard of care. The study consists of a dose-escalation stage, an expansion stage testing MetMAb at the recommended Phase II dose (RP2D), and a dose-escalation stage testing the combination of MetMAb, at two different doses with bevacizumab at a recommended dose.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic documentation of incurable, locally advanced, or metastatic solid malignancy that has failed to respond to at least one prior regimen or for which there is no standard therapy
• Disease that is measurable or evaluable by Response Evaluation Criteria In Solid Tumors (RECIST)
• Life expectancy ≥12 weeks

Exclusion criteria

• Less than 4 weeks since the last anti-tumor therapy
• Patients receiving erythropoietin products
• Active infection requiring antibiotics
• Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
• Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
• Clinically important history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
• Known human immunodeficiency virus infection
• Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 3 patient groups

Stage I

Experimental group

Treatment:

Drug: MetMAb

Drug: MetMAb

Stage II

Experimental group

Treatment:

Drug: MetMAb

Drug: MetMAb

Stage III

Experimental group

Treatment:

Drug: MetMAb

Drug: bevacizumab

Drug: MetMAb