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

ConditionChronic Myelogenous Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen TargetRx Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing to participate in the study with informed consent;

At least 18 years of age at the time of screening;

Any sex;

Diagnosis of CML-CPduring the screening period;

Disqualifiers

Exposure to other antineoplastic therapies prior to study enrollment;

Exposure to other investigational agent(s) within 14 days of initiating TGRX-678 therapy;

Ongoing toxicity from prior therapy greater than grade 1 by CTCAE v. 3 (except alopecia);

Hematopoietic cell transplantation < 60 days prior to the first dose;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: TGRX-678Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recommended dose for expansion (RDE)

To determine the RDE of TGRX-678 in CML patients to be applied in Cohort Expansion part of the study

Time frame
Time Frame: At end of Dose Escalation part of study, an average of 1 year
2

Safety profile (DLT)

to record and analyse subjects with dose-limiting toxicities (DLTs)

Time frame
Time Frame: DLT: collect during Cycle 1 (28 days)
3

Safety profile (AEs/SAEs)

to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)

Time frame
AE and SAE: through completion of the study, an average of 2 years
4

Recommended phase II dose (RP2D)

To determine the RP2D of TGRX-678 in CML patients for Phase II

Time frame
At completion of the study, an average of 2 years

Secondary outcomes

1

Hematologic Response

To record and analyse the hematologic response of subjects. Subjects will be determined whether complete hematologic response (CHR) or no evidence of leukemia (NEL) is reached.

Time frame
at screening period, weekly in Cycle 1, bi-weekly in Cycle 2 and monthly starting from Cycle 3 (each cycle is 28 days), an average of 1.5 years
2

Cytogenetic Response

To record and analyse the cytogenetic response of subjects subjects will be determined whether partial or complete cytogenetic response (Ph+ \< 35%) is reached.

Time frame
at screening period, end of every 3 Cycles (each cycle is 28 days), an average of 1.5 years
3

Molecular Response

To record and analyse the molecular response of subjects Subjects will be determined whether major molecular response (BCR-ABL1 (IS) no more than 0.1%) is reached.

Time frame
at screening period, end of every 3 Cycles (each cycle is 28 days), an average of 1.5 years
4

Plasma Cmax

Cmax of TGRX-678 as measured in plasma

Time frame
Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen TargetRx Co., Ltd.

Lead sponsor

M.D. Anderson Cancer Center

Collaborator

Source ClinicalTrials.gov
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