Phase 12 Study of AT-1965 to Assess Safety and Early Effects in Adults With Advanced or Recurrent Solid Tumors

What this Trial Is About

Researchers are conducting a first-in-human, multicenter, open-label Phase 12 study to evaluate AT-1965 in patients with advanced, refractory, or recurrent solid tumors, including metastatic triple-negative breast cancer. The study aims to identify the maximum tolerated dose or recommended Phase 2 dose of AT-1965 and to assess dose limiting toxicities, safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. Participants will receive AT-1965 Liposome Injection administered intravenously once weekly on Days 1, 8, and 15 of each 28-day treatment cycle. The study consists of a dose escalation phase to determine safe dosing followed by a dose expansion phase to further evaluate the treatment in a larger group. Treatment cycles repeat every 28 days, with dosing and assessments continuing as per protocol. During the study, participants will undergo safety monitoring, pharmacokinetic and pharmacodynamic testing, and tumor assessments using RECIST criteria at 3, 6, and 9 months. Adverse events and serious adverse events will be tracked from consent through 30 days after the last dose. Laboratory tests and clinical evaluations occur regularly during treatment cycles. The total participation duration varies, with ongoing safety and efficacy evaluations throughout the study period.

Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors