Solid TumorPhase 1NCT04970992
A Pharmacokinetic and Pharmacodynamic Study of DZ-002 in Patients With Advanced Solid Malignancies or Lymphoma
A Phase 1 study testing DZ-002 in people with Solid Tumor and Lymphoma, run by Da Zen Theranostics Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Lymphoma
- What is being tested?
- DZ-002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 1 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 17Show fewer
- 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);
- Negative pregnancy test for women of childbearing potential (women of childbearing potential and men must agree to use adequate contraception [hormonal or barrier method of birth control] prior to study entry and for the duration of study participation.
- [NOTE: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient]. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately).
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
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.
Read the detailed description
This is a single center, first-in-human, Phase 1, safety, PK and pharmacodynamic study of DZ-002 in patients with solid tumors who have failed standard therapies. The study will be conducted in 2 phases, a dose escalation phase and a dose expansion phase. The dose-escalation phase will first determine the MTD and/or RP2D of DZ-002 in patients with advanced cancers. Subsequently, the MTD and/or RP2D will be investigated in 2 expansion treatment groups of castration-resistant prostate cancer (CRPC) and advanced pancreatic cancer. Patients who are determined to be eligible, based on Screening assessments, will be enrolled in the study and will receive their first dose of study therapy on Cycle 1 Day 1. All patients will receive DZ-102 administered as a weekly intravenous (IV) infusion on days 1, 8, 15, and 22 of a 28-day cycle. The dose of DZ-002 will be dependent on the cohort in which the patient is enrolled.
- Conditions
- Solid Tumor, Lymphoma
- Being tested
- DZ-002
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZ-002Drug
DZ-002 Injection
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation and cohort expansion Q1W | Experimental | DZ-002 treatment once every week Receives: Drug: DZ-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
MTD
maximum tolerated dose (MTD) of DZ-002
Measured: 24 months
Secondary outcomes (7)
Tumor response
Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and the Prostate Cancer Working Group 3 (PCWG3) for prostate cancer
Measured: 24 months
AUC
Area Under the Plasma Concentration versus Time Curve of DZ-002
Measured: 56 days
Cmax
Maximum Plasma Concentration of DZ-002
Measured: 56 days
Tmax
Time to reach maximum (peak) plasma concentration of
Measured: 56 days
t1/2
Terminal half-life of DZ-002
Measured: 56 days
Clearance
Total body clearance of the drug from plasma (CL) of DZ-002
Measured: 56 days
Volume of distribution
Apparent volume of distribution of DZ-002
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start12 Aug 2021
- Primary completion7 Nov 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Da Zen Theranostics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert L De Jager, MD, Study director, Dazen Theranostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970992
- Sponsor's protocol ID
- DZ-002-101
- Status last verified
- Aug 2025
- First submitted
- 7 Jul 2021
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic and Pharmacodynamic Study of DZ-002 in Patients With Advanced Solid Malignancies or Lymphoma
- ClinicalTrials.gov ID
- NCT04970992
- Acronym / sponsor ID
- DZ-002-101
- Conditions
- Solid Tumor, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Da Zen Theranostics IncIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single center, first-in-human, Phase 1, safety, PK and pharmacodynamic study of DZ-002 in patients with solid tumors who have failed standard therapies. The study will be conducted in 2 phases, a dose escalation phase and a dose expansion phase. The dose-escalation phase will first determine the MTD and/or RP2D of DZ-002 in patients with advanced cancers. Subsequently, the MTD and/or RP2D will be investigated in 2 expansion treatment groups of castration-resistant prostate cancer (CRPC) and advanced pancreatic cancer. Patients who are determined to be eligible, based on Screening assessments, will be enrolled in the study and will receive their first dose of study therapy on Cycle 1 Day 1. All patients will receive DZ-102 administered as a weekly intravenous (IV) infusion on days 1, 8, 15, and 22 of a 28-day cycle. The dose of DZ-002 will be dependent on the cohort in which the patient is enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation and cohort expansion Q1W | Experimental | Drug: DZ-002DZ-002 treatment once every week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DZ-002DZ-002 Injection | Drug | Dose escalation and cohort expansion Q1W |
Primary outcome
Incidence and severity of treatment emergent adverse events (TEAEs)
Time frame: 24 months
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
MTD
Time frame: 24 months
maximum tolerated dose (MTD) of DZ-002
7 secondary outcomes
Tumor response
Time frame: 24 months
AUC
Time frame: 56 days
Cmax
Time frame: 56 days
Tmax
Time frame: 56 days
t1/2
Time frame: 56 days
Clearance
Time frame: 56 days
Volume of distribution
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert L De Jager, MD study director
Dazen Theranostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DZ-002 in people with Solid Tumor and Lymphoma, run by Da Zen Theranostics Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment emergent adverse events (TEAEs) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.