A Study of the Safety and Pharmacokinetics of MEGF0444A Administered to Patients With Advanced Solid Tumors

NCT ID: NCT00909740

Last Updated: 2022-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-22
• Study Completion Date: 2011-10-26

Brief Summary

This is a Phase I, first-in-human, open-label, dose-escalation study of MEGF0444A administered by IV infusion to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable.

Conditions

Solid Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

MEGF0444A

Intervention Type: DRUG

Intravenous escalating dose

Interventions

MEGF0444A

Intravenous escalating dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on, or failed to respond to regimens or therapies known to provide clinical benefit

Exclusion Criteria

• Inadequate hematologic and organ function
• Anti-cancer therapy within 4 weeks prior to initiation of study treatment
• Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
• Active infection or autoimmune disease
• Pregnancy (positive pregnancy test) or lactation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louie Naumovski, M.D., Ph.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

MEF4693g

Identifier Type: -

Identifier Source: org_study_id