A Phase 1 Study of IMC-11F8 in Patients With Advanced Solid Tumors
This single center, open-label, single-arm, Phase 1 study will enroll 18 patients at a
maximum. The actual size will vary depending on the dose-limiting toxicities (DLTs) observed
and the resultant sizes of the cohorts. Patients will receive IMC-11F8 administered
intravenously, once every 2 weeks or on Days 1 and 8 every 3 weeks for 6 weeks (one cycle).
All infusions can be administered within ± 1 day of the scheduled administration date.
After one cycle of treatment, patients who have an objective response or stable disease may
continue to receive IMC-11F8 at the same dose and schedule until disease progression or
other withdrawal criteria are met.
A minimum of three patients will be enrolled in each cohort. Dose escalation in successive
cohorts will occur once all patients complete one cycle of therapy.
Patients will be enrolled sequentially into each cohort. A completed patient will be either
a patient who completes the initial 6 week treatment period (Cycle 1) or a patient who
discontinues therapy for an IMC-11F8-related toxicity during Cycle 1. Patients who do not
complete the first 6 weeks of treatment for reasons other than an IMC-11F8-related toxicity
will be replaced. Toxicity data for each cohort will be reviewed prior to dose escalation.
Upon completion of all required safety evaluations during the initial 6 weeks, the next
cohort of new patients will be treated at the next higher dose level using a dose escalation
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Summary Listing of Participants Reporting Treatment-Emergent Adverse Events
E-mail: ClinicalTrials@ ImClone.com
Japan: Ministry of Health, Labor and Welfare