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TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia

NCT06088888 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-02-21

No results posted yet for this study

Summary

The purpose of this single-arm, open-label, dose escalation + cohort expansion study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-678 in Chronic Myelogenous Leukemia patients who had failure with or are intolerant to TKI treatments.

Conditions

  • Chronic Myelogenous Leukemia

Interventions

DRUG

TGRX-678

Participants are given TGRX-678 tablets orally, once daily, at one of the dose levels as pre-determined for the dose escalation sequence or expansion cohorts.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Shenzhen TargetRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Elias Jabbour · The University of Texas MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-02
Primary Completion
2027-03-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06088888 on ClinicalTrials.gov