MedTrace Logo

Subjects With Advanced or Metastatic Solid Tumor Malignancies

NCT05474859 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-31

No results posted yet for this study

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).

Conditions

  • Metastatic Solid Tumor
  • Advanced Solid Tumor

Interventions

DRUG

XT-0528

Once Daily

Sponsors & Collaborators

  • Xenthera, Inc.

    lead INDUSTRY

Principal Investigators

  • Lynne Kelley, MD · Xenthera, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2028-01-31
Completion
2028-06-30
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05474859 on ClinicalTrials.gov