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TGRX-814 Chinese Phase I/II in Patients With Hematological Malignancies

ConditionsHematologic MalignancyNon Hodgkin LymphomaAcute Myeloid LeukemiaAcute Lymphoblastic Leukemia, AdultMyelodysplastic Syndromes
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen TargetRx Co., Ltd.

About this trial

The purpose of this single- arm, open-label, dose escalation and dose expansion phase I/II study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-814 in patients with hematological malignancies including non-Hodgkin lymphoma, acute myeloid leukemia, aute lymphoblastic leukemia and myelodysplastic syndromes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

male or female ≥ 18 years of age

fully understand the requirements of the study and voluntarily sign a written informed consent form

diagnosis of NHL, ALL, AML or MDS

Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2

Disqualifiers

received BCL-2 inhibitor therapy prior to the first dose of study drug, unless discontinued due to intolerance

subjects with NHL have been diagnosed with Burkitt's lymphoma, lymphoblastoid lymphoma/leukemia, or post-transplant lymphoproliferative disease (PTLD)

AML subjects with a diagnosis of acute promyelocytic leukemia or Ph chromosome positive or persistent extramedullary leukemia

tumor infiltration of the central nervous system

Trial design

Design model

Single group

Treatments tested in this trial

  • TGRX-814

    Drug

    Participants are given TGRX-814 tablets for oral, once daily administration at one of the dose levels as pre-determined for the dose escalation sequence.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: TGRX-814Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximal tolerated dose (MTD)

To determine the MTD of TGRX-814 in non-Hodgkin lymphoma (NHL) patients

Time frame
At end of dose escalation when the probability of DLT of a dose level is greater than 0.359
2

Recommended phase II dose (RP2D)

To determine the RP2D of TGRX-814 in NHL patients for Phase II

Time frame
At completion of the dose escalation study, an average of 1 year

Secondary outcomes

1

Dose-limiting toxicities (DLTs)

to record and analyze DLTs in all patients with hematological malignancies

Time frame
DLT is collected during Cycle 1 (each cycle is 28 days)
2

Adverse Events (AEs)/Serious Adverse Events (SAEs)

to record and analyze AEs/SAEs in all patients with hematological malignancies

Time frame
AE and SAE are collected throughout and until completion of the study, an average of 1 year.
3

Complete Response (CR) rate

to record and analyze the CR rate in patients with NHL, ALL, AML, and MDS

Time frame
at screening period, at the end of week 8, 16, 24, 36, 48, subsequent every 24 weeks and the last visit of treatment period, at the end-of-treatment follow-up visit and safety follow-up visit
4

Complete response with incomplete count recovery (CRi) rate

to record and analyze the CRi rate in patients with NHL, ALL, and AML

Time frame
at screening period, at the end of week 8, 16, 24, 36, 48, subsequent every 24 weeks and the last visit of treatment period, at the end-of-treatment follow-up visit and safety follow-up visit

Other outcomes

Sponsors and contacts

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

Shenzhen TargetRx Co., Ltd.

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Collaborator

Source ClinicalTrials.gov
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