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DZ-002 for Cancer

Phase 1

Recruiting

Research Sponsored by Da Zen Theranostics Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is to test the safety of DZ-002 and to see what dose is tolerated by patients with solid tumors. They will also assess how the drug works against tumors.

Who is the study for?

Adults with advanced solid tumors or lymphoma that haven't responded to standard treatments can join this trial. They must be able to follow the study plan, have a life expectancy over 8 weeks, and good organ function. Women of childbearing age need a negative pregnancy test and agree to use birth control.Check my eligibility

What is being tested?

The study is testing DZ-002's safety and finding the highest dose patients can take without serious side effects (MTD). It also aims to find the best dose for future studies (RP2D) while checking how the body processes it and its effectiveness against tumors.See study design

What are the potential side effects?

Possible side effects of DZ-002 are not detailed in this summary but typically include reactions at injection sites, fatigue, nausea, liver issues, blood count changes, or allergic responses based on similar cancer drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and severity of treatment emergent adverse events (TEAEs)

MTD

Secondary outcome measures

AUC

Clearance

Cmax

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose escalation and cohort expansion Q1WExperimental Treatment1 Intervention

DZ-002 treatment once every week

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Da Zen Theranostics IncLead Sponsor

Robert L De Jager, MDStudy DirectorDazen Theranostics

Media Library

DZ-002 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04970992 — Phase 1

Lymphoma Research Study Groups: Dose escalation and cohort expansion Q1W

Lymphoma Clinical Trial 2023: DZ-002 Highlights & Side Effects. Trial Name: NCT04970992 — Phase 1

DZ-002 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04970992 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any participants needed for this clinical investigation?

"As per clinicaltrials.gov, this investigation is still open for enrolment. It was first advertised on August 12th 2021 and its details were last revised on March 2nd 2022."

Answered by AI

What is the total participant count of this research project?

"Indeed, the clinicaltrial.gov repository reveals that this medical trial is currently actively recruiting patients; initially posted on August 12th 2021 and most recently updated in March 2nd 2022, it seeks to enlist 55 participants from a single site."

Answered by AI

Has the Food and Drug Administration sanctioned DZ-002 for public use?

"Currently, the safety of DZ-002 has been assessed as a 1 due to this being only a Phase 1 trial. This means there is limited evidence validating its efficacy and no large scale data on its security."

Answered by AI

What outcome is this experiment aiming to accomplish?

"This 24 month clinical trial seeks to determine the Maximum Tolerated Dose (MTD) of its drug. Additionally, Total Body Clearance (CL), Area Under the Plasma Concentration versus Time Curve (AUC), and cancer-specific responses as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for solid tumors or [Prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) Working Group 3 (PCWG3) criteria for prostate cancer will be tracked as secondary objectives."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Pharmacokinetic and Pharmacodynamic Study of DZ-002 in Patients With Advanced Solid Malignancies or Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04970992.