Trials / Active Not Recruiting
Active Not RecruitingNCT05434312
TGRX-678 Chinese Phase I in Chronic Myelogenous Leukemia (CML) Patients
A Single-arm, Open-label, Dose Escalation and Dose Expansion Phase 1 Trial to Determine the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-678 in Patients With Refractory or Advanced CML
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Shenzhen TargetRx Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is the first-in-human trial with TGRX-678 which aims to evaluate the safety profile and preliminary efficacy profile in advanced or refractory CML patients with previous failure or intolerence to TKI treatments. The primary purpose of this study is to evaluate the safety profile of TGRX-678, including determination of the maximal tolerated dose (MTD) and recommended phase II dose (RP2D), and other safety measures of the investigational drug, such as adverse events and abnormal clinical outcomes. Preliminary efficacy profile of TGRX-678 is evaluated based on the changes in peripheral blood cells and disease-associated cytogenetic markers. The safety, tolerability and efficacy profiles, along with pharmacokinetic analysis, will be assessed together to determine the optimal dose for expansion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TGRX-678 | Participants are given TGRX-678 tablets orally at one of the dose levels as pre-determined for the dose escalation sequence. |
Timeline
- Start date
- 2021-03-29
- Primary completion
- 2026-03-01
- Completion
- 2026-09-01
- First posted
- 2022-06-28
- Last updated
- 2025-02-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05434312. Inclusion in this directory is not an endorsement.