A Phase I, Multi-Dose Study of RAV12 (ANTI-RAAG12 MAB) in Patients With Metastatic or Recurrent Adenocarcinoma
- Determine the maximum tolerated dose of RAV12 in patients with metastatic or recurrent
- 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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity by CTCAE
Stanford J Stewart, MD
United States: Food and Drug Administration
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|
|Sarah Cannon Cancer Center at Centennial Medical Center||Nashville, Tennessee 37203|
|Premiere Oncology||Santa Monica, California 90404|