Phase 1 Study of AN4005 to Find Safe Doses for Patients with Advanced Solid Tumors or Lymphoma

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of AN4005 in adults with advanced solid tumors or lymphoma for whom standard treatments are not available or suitable. This is a first-in-human, open-label, multicenter phase 1 trial designed to find the maximum tolerated dose MTD and the recommended phase 2 dose RP2D of AN4005. The study uses a dose escalation design to carefully assess safety and side effects in participants. Participants receive oral doses of AN4005 starting with a sentinel patient at 50 mg twice daily BID. Subsequent cohorts of three patients receive increasing doses ranging from 100 mg BID up to 600 mg BID, with dose adjustments based on safety and dose-limiting toxicities observed during initial treatment cycles. A separate group will evaluate how a high-fat meal affects the drugs pharmacokinetics after a safe dose is identified. Dose escalation decisions are made jointly by investigators and sponsors. During the study, participants will be closely monitored for adverse events, serious adverse events, and dose-limiting toxicities over about one year. Laboratory tests, vital signs, physical exams, and organ function assessments will be performed. Researchers will measure drug concentrations in the blood to understand its behavior and will assess cancer response using established criteria. Follow-up includes safety evaluations up to 90 days after treatment ends.

First in Human, Dose Escalation Study of AN4005