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

Genentech

Status and phase: Completed; Phase 1

Conditions: Solid Cancers

Treatments: Drug: MEGF0444A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909740

MEF4693g

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

1

Experimental group

Treatment:

Drug: MEGF0444A