Trials / Completed
CompletedNCT05269940
A Study to Evaluate Activity, Safety and Tolerability of ZX-101A in Relapsed/Refractory Hematological Malignancies
A Phase I/II Study Evaluating ZX-101A in Patients with Relapsed/Refractory Hematological Malignancies
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Nanjing Zenshine Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
ZX-101A-202 is a Phase I, open-label, multicenter study, a single-agent dose-escalation and dose-expansion study of ZX-101A. It is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacokinetics, efficacy and antitumor activity of ZX-101A in patients with relapsed/refractory hematological malignancies.
Detailed description
Phase I includes two parts: dose escalation and dose expansion. It's mainly to explore the safety and tolerability of ZX-101A in patients with relapsed/ refractory hematological malignancies \[Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), indolent NHL, and other NHL subtypes\], and to determine RP2D. * Part 1. ZX-101A dose escalation * Part 2. ZX-101A dose expansion in two specific types of lymphoma, i.e. PTCL /CTCL or one B-iNHL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ZX-101A | oral dosing, once daily |
Timeline
- Start date
- 2022-02-17
- Primary completion
- 2023-01-24
- Completion
- 2024-07-05
- First posted
- 2022-03-08
- Last updated
- 2024-11-13
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05269940. Inclusion in this directory is not an endorsement.