NCT05474859

Subjects With Advanced or Metastatic Solid Tumor Malignancies

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xenthera, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Metastatic Solid Tumor
• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	XT-0528	Once Daily

Timeline

• Start date: 2024-12-01
• Primary completion: 2028-01-01
• Completion: 2028-06-01
• First posted: 2022-07-26
• Last updated: 2024-07-31

Regulatory

• FDA-regulated drug study