Trials / Recruiting
RecruitingNCT06206174
TGRX-814 Chinese Phase I/II in Patients With Hematological Malignancies
A Single-arm, Open-label, Dose Escalation and Expansion Phase I/II Study Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-814 Monotherapy and Combination Therapy in Patients With Hematological Malignancies
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Shenzhen TargetRx Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This is the first-in-human trial with TGRX-814 which aims to evaluate the safety, pharmacokinetic and preliminary efficacy profiles with hematological malignancies. The primary purpose of this study is to evaluate the safety profile of TGRX-814 in patients with non-Hodgkin lymphoma and to determine of the maximal tolerated dose (MTD) and recommended phase II dose (RP2D). Other purposes of the study include evaluating safety and preliminary efficacy of TGRX-814 monotherapy and combination therapy in patients with other types of hematological malignancies, including acute myeloid leukemia, aute lymphoblastic leukemia and myelodysplastic syndromes, as well as evaluating the pharmacokinetic profile of TGRX-814. The study is a phase I/II study, consisting a monotherapy dose escalation study, monotherapy dose expansion study and combination therapy study.
Conditions
- Hematologic Malignancy
- Non Hodgkin Lymphoma
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia, Adult
- Myelodysplastic Syndromes
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TGRX-814 | 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. |
Timeline
- Start date
- 2024-03-06
- Primary completion
- 2025-02-28
- Completion
- 2029-02-28
- First posted
- 2024-01-16
- Last updated
- 2024-04-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06206174. Inclusion in this directory is not an endorsement.