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

A Phase I, Open Label, Dose Escalation 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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01068977

Enrollment

Registered

2010-02-17

Start date

2007-08-31

Completion date

2010-01-31

Last updated

2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Cancers

Brief summary

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.

Interventions

DRUGbevacizumab

Repeating intravenous dose

DRUGMetMAb

Repeating escalating intravenous dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of MetMAb alone or in combination with bevacizumab will be assessed (frequency and nature of dose-limiting toxicities; nature, severity, and relatedness of adverse events; changes in vital signs and clinical laboratory parameters)	Length of study

Secondary

Measure	Time frame
Objective response, defined as a complete or partial response confirmed ≥4 weeks after initial documentation	Length of study
Duration of objective response	Length of study
Progression-free survival	Length of study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026