A Phase 1/2 interventional study of ZX-101A in Non-hodgkin Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Hangzhou Zenshine Pharmaceuticals Co., Ltd.. Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-21.
Sponsored by Hangzhou Zenshine Pharmaceuticals Co., Ltd. · Phase 1/2, Interventional, and Treatment
ZX-101A-101 is a Phase 1/2a, first-in-human, open-label, multicenter, multiple-ascending dose study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary antitumor activity of ZX-101A administered orally (PO) once daily (QD) in 28-day cycles in patients with relapsed/resistant or refractory advanced hematologic malignancies [Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), indolent NHL, and other NHL subtypes).
The ZX-101A-101 study will consist of 2 parts:
The Part 1 (dose escalation) of the study is designed to determine the safety and tolerability of ZX-101A administered orally once daily in 28-day cycles. The Part 2 (dose expansion) of the study is designed to further investigate the safety, tolerability, pharmacokinetics and pharmacodynamic and clinical activities of ZX-101A administered orally once daily in 28-day cycles at the selected recommended Phase 2 dose (RP2D).
Results of clinical findings in patients in the dose-escalation portion of the study will be reviewed to identify conditions (or genetic characteristics) most likely to respond to ZX-101A. These select types of hematologic malignancies will be enrolled in cohorts in the dose-expansion part of the study.
Male or female patients who are 18 years of age or older with relapsed/resistant or refractory advanced hematologic malignancies (CLL/SLL, iNHL, and other NHL subtypes) will be included in the study provided that all inclusion and exclusion criteria are satisfied.
Up to three cohorts are planned in Part 2 - Dose Expansion of the study: 1) relapsed/resistant or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), 2) relapsed/resistant or refractory indolent Non- Hodgkin's Lymphoma (iNHL), and based on emerging data from Part 1-Dose Expansion, a third cohort consisting of other types of NHL may be included.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 6 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →This is the only study on the registry with Hangzhou Zenshine Pharmaceuticals Co., Ltd. as lead sponsor.
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Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Starting dose (SD) of ZX-101A administered orally once daily in a 28-day cycle
Drug: ZX-101A
2-times the SD of ZX-101A administered orally once daily in a 28-day cycle
Drug: ZX-101A
3-times the SD of ZX-101A administered orally once daily in a 28-day cycle
Drug: ZX-101A
4-times the SD of ZX-101A administered orally once daily in a 28-day cycle
Drug: ZX-101A
5-times the SD of ZX-101A administered orally once daily in a 28-day cycle
Drug: ZX-101A
Once daily, oral dosing of ZX-101A at the assigned dose level for 28 consecutive days in a 28-day cycle
Defining the recommended Phase 2 dose (RP2D) of ZX-101A.
To assess number of patients experiencing dose-limiting toxicities (DLTs) in Part 1.
Time frame: From Day 1 of Cycle 1 through the end of the DLT evaluation period (28 days for the first two Dose Levels and 84 days for Dose Levels 3, 4 and 5); each cycle is 28 days.
Safety and tolerability of ZX-101A
To examine the incidence of clinical and laboratory adverse events after multiple doses of ZX-101A in Parts 1 and 2
Time frame: From first dose of ZX-101A through 28 days after the last ZX-101A treatment (up to 2 years); each cycle is 28 days.
Peak Plasma Concentration of ZX-101A
To evaluate the maximum observed concentration (Cmax) after single and repeated oral, once daily doses of ZX-101A
Time frame: Days 1, 2, 15 and 16 of Cycle 1 (each cycle is 28 days), and Day 1 of Cycle 3 and Cycle 5
Area under the plasma concentration of ZX-101A
To evaluate the area under the curve (AUC) plasma-concentration after single and repeated oral, once daily doses of ZX-101A
Time frame: Days 1, 2, 15 and 16 of Cycle 1 (each cycle is 28 days), and Day 1 of Cycle 3 and Cycle 5
Half-life of ZX-101A
To evaluate the half-life of ZX-101A after single and repeated oral, once daily doses of ZX-101A
Time frame: Days 1, 2, 15 and 16 of Cycle 1 (each cycle is 28 days), and Day 1 of Cycle 3 and Cycle 5
Phospho-AKT (p-AKT) levels in whole blood
To evaluate the differences phospho-AKT (p-AKT) levels in whole blood before and after single oral dose of ZX-101A.
Time frame: Days 1 and 2 of Cycle 1 (each cycle is 28 days)
Objective response rate (ORR)
To evaluate the objective response rate (ORR) as determined by the specific disease response criteria
Time frame: Up to 2 years
Duration of response (DoR)
To examine the duration of response (DoR), defined as time from the date of first documentation of response to the date of the first documentation of progressive disease (PD), or death due to any cause
Time frame: Up to 2 years
Progression free survival (PFS)
To examine the the progression free survival (PFS), defined as time from the date of first dose of study treatment to the first date of documentation of PD, or death due to any cause
Time frame: Up to 2 years
Overall survival (OS)
To examine the overall survival (OS), defined as time from the date of first dose of study treatment to death due to any cause
Time frame: Up to 2 years
This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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