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Study of the Safety, Tolerability and Pharmacokinetics of HZ-A-018 in Patients With B Cell Lymphoma

NCT04173455 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-11-22

No results posted yet for this study

Summary

The purpose of this study is to establish the safety, tolerability, pharmacokinetics and RP2D (Recommended Phase II Dose) of orally administered HZ-A-018 in patients with B cell lymphoma who have at least failed or relapsed after first-line treatment.

Conditions

  • Lymphoma, B-Cell

Interventions

DRUG

HZ-A-018

In the dose-escalation part, subjects will be assigned to five cohorts with increaing dose level to determine DLT and MTD during the first 28-day cycle. In the expansion part, subjects will be assigned to two fixed dose corhort.

Sponsors & Collaborators

  • Hangzhou HeZheng Pharmaceutical Co., Ltd

    collaborator UNKNOWN

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Jianzhong Shentu · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-28
Primary Completion
2021-09-30
Completion
2022-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04173455 on ClinicalTrials.gov