drugset
drugset / Trial / NCT05474859

Subjects With Advanced or Metastatic Solid Tumor Malignancies

NCT05474859 ↗

Phase 1 Not yet recruiting 30 enrolled Xenthera, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

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).

Timeline

Start
2024-12
Primary completion
2028-01
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject XT-0528 Unknown 250 mg Oral
Subject XT-0528 Unknown 500 mg Oral
Subject XT-0528 Unknown 1000 mg Oral
Subject XT-0528 Unknown 1500 mg Oral
Subject XT-0528 Unknown 2500 mg Oral

Indications

metastatic neoplasm