TGRX-678

DRUG5 trials

Sponsors

Shenzhen TargetRx, Inc., Shenzhen TargetRx Co., Ltd.

Conditions

Accelerated Phase CMLChronic Myelogenous LeukemiaChronic Myelogenous Leukemia - Chronic PhaseChronic Myeloid Leukemia

Phase 1

TGRX-678 Chinese Phase I in Chronic Myelogenous Leukemia (CML) Patients

Active, not recruitingNCT05434312

Shenzhen TargetRx, Inc.Chronic Myelogenous Leukemia

Start: 2021-03-29End: 2026-09-30Target: 90Updated: 2025-02-24

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

RecruitingNCT06088888

Shenzhen TargetRx, Inc.Chronic Myelogenous Leukemia

Start: 2024-07-02End: 2027-06-30Target: 90Updated: 2025-02-21

TGRX-678 Phase I Oral Pharmacokinetic Study

CompletedNCT06697899

Shenzhen TargetRx, Inc.Chronic Myeloid Leukemia

Start: 2024-11-24End: 2025-02-20Updated: 2025-05-16

Phase 2

TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients

RecruitingNCT06453902

Shenzhen TargetRx, Inc.Accelerated Phase CML, Chronic Myeloid Leukemia

Start: 2024-07-15End: 2028-04-30Target: 40Updated: 2025-02-21

Phase 3

TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients

Not yet recruitingNCT07489755

Shenzhen TargetRx Co., Ltd.Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia - Chronic Phase

Start: 2026-04-01End: 2031-05-01Target: 180Updated: 2026-03-24

Related Papers

Efficacy of tgrx-678, a potent BCR::ABL1 allosteric inhibitor, in CML-CP and CML-AP patients harboring T315I mutation: Results from a phase 1 study

Blood2025-11-03

Safety and Efficacy of Tgrx-678, a Potent <i>BCR::ABL1</i> allosteric Inhibitor, in Patients with Tyrosine Kinase Inhibitor Resistant and/or Intolerant Chronic Myeloid Leukemia: Updated Results of Phase 1 Study Tgrx-678 -1001

Blood2024-11-055 citations

Tgrx-678 Penetrates Blood-Brain Barrier and Exhibits Preclinical Anti-Tumor Activity in Murine Ph+ CNS Leukemia and ALL Models

Blood2024-11-05

Safety and Efficacy of Tgrx-678, a Potent BCR-ABL Allosteric Inhibitor in Patients with Tyrosine Kinase Inhibitor (TKI) Resistant/Refractory Chronic Myeloid Leukemia (CML): Preliminary Results of Phase I Study

Blood2023-11-025 citations

Tgrx-678, a Novel Allosteric Inhibitor of BCR-ABL1, Demonstrates Preclinical Anti-Leukemia Activity, High Oral Bioavailability and Synergism with Ponatinib to Suppress the Highly Resistant Compound Mutations

Blood2023-11-024 citations