Advanced Solid Tumor Clinical Trial
Official title:
A Phase 1, Multicenter Tolerability and Pharmacokinetic Study of Ascending Continuous Oral Doses of XT-0528 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
This study is an open-label, Phase 1, multicenter, continuous dose escalation study of XT-0528 in adult subjects with Advanced or Metastatic Solid Tumor Malignancies. The study will consist of 4 periods: Screening Period (up to 28 days prior to Cycle 1 Day 1) Safety Run-in Period (Cycle 1; continuous dosing on Days 1-21 of 28-day cycle) Continuous Dosing Period (Cycle 2 and beyond; continuous dosing on Days 1-28 of 28-day cycle) Safety Follow-up Period (30 days post-last dose).
Primary Objective - To determine the dose recommended for future Phase 2 studies (RP2D) that maximally suppresses T helper 17 (TH17) cell activities with an absence of dose limiting toxicity (DLT) and without exceeding the maximum tolerable dose (MTD). Secondary Objective - To establish the pharmacokinetics (PK) of orally administered XT-0528. - To observe subjects for evidence of the antitumor activity of XT-0528. ;
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