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TGRX-678 Chinese Phase I in Chronic Myelogenous Leukemia (CML) Patients

NCT05434312 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-02-24

No results posted yet for this study

Summary

The purpose of this single- arm, open-lable, dose escalation + dose expansion study is to evalulate 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 at one of the dose levels as pre-determined for the dose escalation sequence.

Sponsors & Collaborators

  • Peking University People's Hospital

    collaborator OTHER

  • Shenzhen TargetRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Qian Jiang, MD · Peking University People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2026-03-31
Completion
2026-09-30

Countries

  • China

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 NCT05434312 on ClinicalTrials.gov