A Study to Evaluate Activity, Safety and Tolerability of ZX-101A in Relapsed/Refractory Hematological Malignancies

NCT05269940 | Completed Phase 1 DMC

• 1 other identifier: ZX-101A-202
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Non Hodgkin Lymphoma; Peripheral T Cell Lymphoma; CLL/SLL

Outcome Measures

Primary Outcomes (2)

• Defining the RP2D of ZX-101A

  To assess number of patients experiencing dose-limiting toxicities (DLTs)

  From Day 1 of Cycle 1 (each cycle is 28 days) until 28 days after the last dose (up to 2 years)

• To examine the incidence of clinical and laboratory adverse events after multiple doses of ZX-101A

  Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]

  From Day 1 of Cycle 1 (each cycle is 28 days) until 28 days after the last dose (up to 2 years)

Secondary Outcomes (6)

• Objective response rate (ORR)

  Up to 2 years

• Duration of response (DoR)

  Up to 2 years

• Progression free survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

• Plasma Concentration of ZX-101A

  Cycle1Day1 pre-dose and post-dose 0.5, 1 , 2, 4, 6, 8, 24, 48, 72, 96 hours; Cycle1Day13, Day14, Day15 pre-dose and post-dose 0.5, 1, 2, 4 , 6, 8 and 24 hours; Cycle2Day1 pre-dose. Each cycle is 28 days.

Study Arms (5)

ZX-101A Dose Level A

EXPERIMENTAL

ZX-101A administered orally at level A once daily

Drug: ZX-101A

ZX-101A Dose Level B

EXPERIMENTAL

ZX-101A administered orally at level B once daily

Drug: ZX-101A

ZX-101A Dose Level C

EXPERIMENTAL

ZX-101A administered orally at level C once daily

Drug: ZX-101A

ZX-101A Dose Level D

EXPERIMENTAL

ZX-101A administered orally at level D once daily

Drug: ZX-101A

ZX-101A Dose Level E

EXPERIMENTAL

ZX-101A administered orally at level E once daily

Drug: ZX-101A

Interventions

ZX-101A DRUG

oral dosing, once daily

ZX-101A Dose Level A; ZX-101A Dose Level B; ZX-101A Dose Level C; ZX-101A Dose Level D; ZX-101A Dose Level E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females who are ≥ 18 years old
• Minimum life expectancy ≥ 3 months (determined by investigator assessment)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to1.
• Histopathological and cytological confirmed diagnosis of hematological malignancies.
• Phase I dose expansion and phase II studies require at least 1 measurable lesion, including cutaneous T-cell lymphoma \[CTCL\] without evidence of skin involvement.
• Acceptable bone marrow function.
• Acceptable organ function: creatinine clearance ≥ 60 mL/min calculated according to institutional standard practice assessment (according to the Cockcroft-Gault formula) for kidney function; AST and ALT ≤ 2.5 x upper limit of normal (ULN) (AST and ALT ≤ 4 x ULN in subjects with liver involvement); total bilirubin ≤ 1.5 x ULN (total bilirubin ≤ 3 in subjects with Gilbert syndrome ×ULN) for liver function.
• No transfusion or cytokine support for ≥ 2 weeks before first dosing.
• Ability to swallow oral medication.
• Negative serum pregnancy test in women of childbearing potential at screening.
• Females of childbearing potential and males with female partners of childbearing potential must agree to use effective contraception during the study period and for 6 months (females) or 3 months (males) after the last dose of ZX-101A.
• Men must agree to no sperm donation during the study and for 3 months after the last dose of ZX-101A.
• Understands the requirements of the study, is willing to comply with all study procedures and signed the IRB-approved informed consent.

You may not qualify if:

• Previous use of PI3K δ/γ dual inhibitors
• Received approved anti-cancer drugs within 28 days (42 days for nitrosoureas) or 5 half-lives, whichever is longer.
• Radiation treatment within 2 weeks prior to first dose of study treatment.
• Received investigational study drug within 28 days (or 5 half-lives, whichever is longer).
• Received organ transplantation in the past (hematopoietic stem cell transplantation in the past is allowed).
• Major surgery within 28 days prior to the first dose of study drug
• Has not recovered from adverse events from prior anti-cancer treatment (with exception of alopecia).
• Concurrent participation in another therapeutic treatment trial.
• Those who have been vaccinated with live vaccines or live attenuated vaccines within 30 days before the first administration, and seasonal influenza vaccines without live viruses are allowed.
• Received warfarin or factor Xa inhibitor within 5 half-lives before the first dose of study drug.
• With central nervous system (CNS) involvement or active leptomeningeal disease.
• History of other malignancy within the past 5 years, unless cured by surgery and sustained disease-free survival.
• CLL with Richter transformation.
• Active autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
• Chronic immunosuppression conditions.

Sponsors & Collaborators

• Nanjing Zenshine Pharmaceuticals: lead

Study Sites (3)

Anhui Medical University No.4 Affiliated Hospital

Hefei, Anhui, China

Location

Wuhan Union Hospital

Wuhan, Hubei, China

Location

Hunan Tumor Hospital

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell

Study Officials

• Xiaolin Qin, PhD

  Zenshine Pharmaceutical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: March 8, 2022
• Study Start: February 17, 2022
• Primary Completion: January 24, 2023
• Study Completion: July 5, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

CN (3)