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

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MEGF0444A, Administered Intravenously to Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Completed
• Conditions: Solid Cancers
• Intervention / Treatment: Drug: MEGF0444A

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: MEGF0444A; Intravenous escalating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and nature of dose-limiting toxicities (DLTs)	Days 1-21 of cycle 1
Incidence, nature, relatedness, and severity of adverse events	Day 1 to study completion

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution	Following administration of study drug

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Louie Naumovski, M.D., Ph.D., Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2009
• Primary Completion (Actual): October 26, 2011
• Study Completion (Actual): October 26, 2011

Study Registration Dates

• First Submitted: May 20, 2009
• First Submitted That Met QC Criteria: May 26, 2009
• First Posted (Estimate): May 28, 2009

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Solid Tumor
• Other Study ID Numbers: MEF4693g