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

Part of paid clinical trials in Houston, Texas.

Sponsor
Shenzhen TargetRx Co., Ltd.
Study ID
NCT06088888
Phase
PHASE1
Status
Recruiting
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Conditions

  • Chronic Myelogenous Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TGRX-678 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 2, 2024
Status verified
Feb 2025
Primary completion
Mar 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TGRX-678
    Subjects to be treated with the investigational drug TGRX-678

Primary Outcome Measure

Recommended dose for expansion (RDE) [ Time Frame: Time Frame: At end of Dose Escalation part of study, an average of 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Elias Jabbour, MD
[email protected]
713-792-4764
Fred Hutchinson Cancer CenterSeattleWashington98102
Vivian Oehler, MD
[email protected]
206-667-1340

Find similar trials in Houston, TX

By research site
The University of Texas MD Anderson Cancer Center· Houston, TXFred Hutchinson Cancer Center· Seattle, WA

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