Assessing an Oral Bruton Tyrosine Kinase Inhibitor, DZD9008 in Patients Who Have Non-Hodgkin B-cell Lymphoma (WU-KONG3)

NCT04148742 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: DZ2019B0001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This study will treat patients with non-Hodgkin B-cell lymphoma who have relapsed from, refractory or intolerant to prior therapy. This study will help understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.

Conditions

Non-Hodgkin's B-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Part A: Incidence of Treatment-Emergent Adverse Events

  Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0

  Through study completion, an average of 1.5 years

• Part B: objective response rate (ORR)

  Through study completion, an average of 1.5 years

Secondary Outcomes (2)

• Maximum Plasma DZD9008 concentration

  up to 16 weeks

• Plasma DZD9008 concentration- Area Under the Curve

  up to 16 weeks

Study Arms (1)

daily dose of DZD9008

EXPERIMENTAL

daily dose of DZD9008

Drug: DZD9008

Interventions

DZD9008 DRUG

Daily dose of DZD9008, except for cycle 0 of Part A, in which a single dose of DZD9008 is administrated. Starting dose of DZD9008 is 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD9008.

daily dose of DZD9008

Eligibility Criteria

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

You may qualify if:

• Aged at least 18 years old.
• Patients must be willing and able to participate in all required evaluations and procedures.
• Patients must be able to provide a signed written informed consent.
• With documented histologically confirmed diagnosis of CLL/SLL, MCL or MZL and have least 1 measurable site of disease. Subjects must have relapsed, or are refractory or intolerant to \>= 2 lines of prior therapy, and without preferred alternative treatment as judged by investigator. For Part B, subjects should be either BTK inhibitor treatment naive or intolerant to prior BTK inhibitor within 6 months on treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Predicted life expectancy ≥ 12 weeks.
• Adequate organ system functions.

You may not qualify if:

• Prior malignancy requires active treatment within 2 to 3 years.
• A life-threatening illness, medical condition or organ system dysfunction.
• Radiotherapy with a limited field of radiation for palliation within 1 week of the screening.
• Major surgery within 4 weeks before screening.
• Prior treatment with any onco-immunotherapy within 4 weeks before screening.
• Subjects require immediate cytoreduction.
• Any history of Richter's transformation.
• Central nervous system (CNS) involvement unless previous treated and asymptomatic.
• Requires anticoagulation therapy with Warfarin, heparin.
• Known history of human immunodeficiency virus (HIV); Positive Hepatitis B surface antigen (HbsAg) or positive HCV antibodies; any other uncontrolled active systemic infection.
• Any of the following cardiac criteria: (1) mean resting corrected QT interval (QTcF) \> 470 msec obtained from 3 electrocardiograms (ECGs). (2) prior history of atrial fibrillation. (3) any factors that increase the risk of QTcF prolongation, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
• History of stroke or intracranial haemorrhage.
• Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
• History of hypersensitivity.

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (2)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Nanjing, China

Location

Jiangsu Province Hospital - Haematology

Nanjing, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Jianyong Li

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 1, 2019
• Study Start: August 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)