NCT00101972

RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma

A Phase I, Multi-Dose Study of RAV12 (ANTI-RAAG12 MAB) in Patients With Metastatic or Recurrent Adenocarcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: MacroGenics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of RAV12 in treating patients with metastatic or recurrent adenocarcinoma.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of RAV12 in patients with metastatic or recurrent adenocarcinoma. * Determine the toxicity profile of this drug in these patients. * Determine the pharmacokinetics and immunogenicity of this drug in these patients. * Determine, preliminarily, the antitumor activity of this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive RAV12 IV over 2 hours 2-3 times per week in weeks 1-4 (course 1). Patients are evaluated for response on day 43. Patients achieving a partial or complete response may be eligible to receive additional courses of RAV12 as above. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of RAV12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Up to 15 additional patients are treated at the MTD in 1 or more patients groups (e.g., colorectal, pancreatic, gastroesophageal, and other adenocarcinoma). After completion of study treatment, patients are followed within 4 weeks and then every 6-12 months thereafter. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Conditions

• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	monoclonal antibody RAV12	Escalating doses of RAV12 (weekly 0.3, 1.0, 1.5, 3.0, 4.0, 5.0, 6.0 mg/kg or 0.5 mg/kg BIW or TIW; 0.75 mg/kg BIW) for 4 weeks

Timeline

• Start date: 2004-12-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2005-01-19
• Last updated: 2022-02-22

Locations

5 sites across 1 country: United States