At a glance
ClinicalIndex Comparison RecordPhase 1Recruiting· 90 target
Drug / intervention
TGRX-678drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-arm, Open-label, Dose Escalation + Cohort Expansion Phase 1 Trial on Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-678 in Subjects with Refractory or Advanced Chronic Myelogenous Leukemia
In Brief
A Phase 1 clinical trial evaluating TGRX-678 for Chronic Myelogenous Leukemia. Currently recruiting, targeting 90 participants across 2 sites.
Signals
Enrolling ahead of pace
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myelogenous Leukemia
CountriesUnited States
CollaboratorsM.D. Anderson Cancer Center
Timeline
Phase 1Recruiting
2024202520262027
First PostedOct 2023
Enrollment StartJul 2024
TodayJul 2026
Primary CompletionMar 2027
Study CompletionJun 2027
First PostedOct 18, 2023
Enrollment StartJul 2, 2024
Primary CompletionMar 30, 2027
Study CompletionJun 30, 2027
TodayJul 1, 2026
Enrollment to primary: 2.7 yearsPosted 2.7 years agoPrimary completion in 9 months
Interventions
TGRX-678drug
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.