A Pharmacokinetic and Pharmacodynamic Study of DZ-002 in Patients With Advanced Solid Malignancies or Lymphoma

NCT04970992 | Completed Phase 1 FDA Drug

• 1 other identifier: DZ-002-101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this Phase 1 study is to characterize the safety and tolerability of DZ-002 and establish the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of DZ-002 administered on a weekly schedule in patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of DZ-002 will also be assessed.

Conditions

Solid Tumor; Lymphoma

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of treatment emergent adverse events (TEAEs)

  Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit

  24 months

• MTD

  maximum tolerated dose (MTD) of DZ-002

  24 months

Secondary Outcomes (7)

• Tumor response

  24 months

• AUC

  56 days

• Cmax

  56 days

• Tmax

  56 days

• t1/2

  56 days

Study Arms (1)

Dose escalation and cohort expansion Q1W

EXPERIMENTAL

DZ-002 treatment once every week

Drug: DZ-002

Interventions

DZ-002 DRUG

DZ-002 Injection

Dose escalation and cohort expansion Q1W

Eligibility Criteria

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

You may qualify if:

• Histopathologically confirmed diagnosis of an advanced, unresectable, or metastatic solid malignant tumor (including lymphoma; dose-escalation phase only) that has failed to respond to standard therapies;
• Male or female patients age 18 or older;
• Measurable or evaluable disease by RECIST v 1.1, or PCWG3 for prostate cancer;
• Capable of understanding and complying with protocol requirements;
• A life expectancy of greater than 8 weeks at Screening;
• An ECOG PS of 0 to 2;
• Written informed consent from the patient or the patient's legally acceptable representative prior to the initiation of any study procedures;
• Adequate bone marrow, liver, and renal function as defined below:
• Hemoglobin ≥ 8.0 g/dL (transfusions and/or erythropoietic stimulating growth factors allowed);
• Absolute neutrophil count ≥ 1500/μL;
• Platelet count ≥ 75,000/ μL;;
• Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 × the upper limit of normal (ULN) or ≤ 5 × ULN for patients with known hepatic metastases;
• Total serum bilirubin ≤ 1.5× ULN or ≤ 2 .0 × ULN if liver metastases are present. Patients with a known history of Gilbert's syndrome (≤ 3.0 × ULN) and/or isolated elevations of indirect bilirubin are eligible for study participation;
• Estimated creatinine clearance ≥ 40 mL/min(using the Cockcroft Gault formula);
• Adequate cardiac function as estimated by left ventricular ejection fraction (LVEF) \> 50% by multiple-gated acquisition (MUGA) or echocardiogram (ECHO);

You may not qualify if:

• New York Heart Association (see Appendix 5) Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, a history of risk factors for Torsades de Pointes, including heart failure, hypokalemia, and family history of long QTc syndrome, or evidence of ischemia on ECG;
• Baseline QTc exceeding 470 msec (using the Fridericia's formula) and/or patients receiving Class 1A or Class III antiarrhythmic agents or concomitant medications that prolong the QT/QTc interval;
• Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy;
• Treatment with simvastatin unless it can be stopped prior to and during the study.
• Treatment with strong inhibitors and inducers of CYP3A4 or narrow therapeutic index substrates of CY3A4, CYP2B6, CYP1A2, CYP2C9 and CYP2C8, unless these can be stopped prior to and during the study
• Known sensitivity to DZ-002 or drug excipients
• Pregnant (confirmed by serum or urine pregnancy test) or is breast feeding;
• Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 30 days prior to study entry (6 weeks for nitrosoureas or Mitomycin C);
• Unwillingness or inability to comply with procedures required in this protocol;
• Known infection with human immunodeficiency virus and CD4 lymphocyte count \< 200 cells/mm3 , or active hepatitis B virus, or hepatitis C virus infections;
• Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the Sponsor;
• Patients who are currently receiving any other investigational agent.

Sponsors & Collaborators

• Da Zen Theranostics Inc: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Robert L De Jager, MD

  Dazen Theranostics

  STUDY DIRECTOR

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: July 7, 2021
• First Posted: July 21, 2021
• Study Start: August 12, 2021
• Primary Completion: November 7, 2024
• Study Completion: April 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (1)