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Metastatic Pancreatic AdenocarcinomaPhase 2DZ-002-201NCT07344220

Metastatic Non-Familial Adenocarcinoma Maintenance Therapy With DZ-002: Heptamine Carboxymethine Dye Conjugate

A Phase 2 study testing DZ-002 - 5 mg/kg, 6 mg/kg, or 7 mg/kg in people with Metastatic Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if drug DZ-002 works to treat adults with metastatic pancreatic adenocarcinoma. It will also learn about the safety of drug DZ-002. The main questions it aims to answer are: To determine the appropriate dose of DZ-002; and To assess the safety and efficacy of DZ-002. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DZ-002 - 5 mg/kg, 6 mg/kg, or 7 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
5 Mar 2026to Apr 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 metastatic pancreatic adenocarcinoma who completed 4 months or more of first line chemotherapy and have achieved at least SD documented by CT scan.
  • Male or female patients ≥18 years of age;
  • Measurable or evaluable disease by RECIST v 1.1;
  • Capable of understanding and complying with protocol requirements;
  • A life expectancy of greater than 8 weeks at Screening;
  • ECOG PS of 0 to 1;
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  • 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 ≥ 10.0 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)
  • 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);
  • Adequate pulmonary function tests with FEV 1 >90% and Vital capacity >90%

Who cannot join

  • New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, a history of risk factors for Torsades de Points, 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;
  • Patients with individual pulmonary metastases > 5 cm diameter or with high metastatic burden to the lungs as determined by the principal or the primary investigator;
  • Patients with extensive bone metastases as determined by the principal or the primary investigator;
  • Patients with a current positive COVID-19 diagnosis, or are currently symptomatic with COVID-19, or who have had COVID-19 in the last month, or with a history of COVID-19 diagnosis with respiratory complications;
  • Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy;
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  • 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 its excipients;
  • Pregnant (confirmed by serum or urine pregnancy test) or is breast feeding;
  • Unwillingness or inability to comply with procedures required in this protocol;
  • Known infection with human immunodeficiency virus and CD4 lymphocyte count ≤ 200 cells/mm3, 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
  • Patients with G6PD deficiency or hereditary methemoglobinemia
  • Patients taking the following medications: Nitroglycerine, dapsone or antimalarials (e.g. chloroquine, primaquine)
  • Patients with known pulmonary disease

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

Other trials in United States

About this study

The goal of this clinical trial is to learn if drug DZ-002 works to treat adults with metastatic pancreatic adenocarcinoma. It will also learn about the safety of drug DZ-002. The main questions it aims to answer are:

  • To determine the appropriate dose of DZ-002; and
  • To assess the safety and efficacy of DZ-002.
Read more

Participants will receive one of three different doses of the study drug through an IV over a 4-hour period on Days 1, 8, 15, and 22 of a 4-week period, or cycle. During the study, participants will have regular visits to the study clinic and multiple tests for safety and research purposes, including blood tests, along with other tests and scans. Participants will receive the study drug weekly in 4-week (28-day cycles) until there are side effects that cannot be tolerated, there is disease-worsening, or the researchers decide to stop. A post-treatment visit and a 30-day post-treatment follow up visit will be conducted after the last dose of study drug.

Risks of DZ-002 include nausea, vomiting, diarrhea, chills, low levels of red blood cells, low levels of platelets, fatigue, skin rash, low blood pressure, and feeling unwell.

Read the detailed description

This is an open label, non-randomized, Phase 2 study to asses the efficacy, safety, PK and pharmacodynamic study of DZ-002 in patients with metastatic pancreatic adenocarcinoma who have completed four or more months of first line chemotherapy with a response of stable disease, partial response, or complete response as documented by CT.

There are two parts in this study, a dose escalation part and a dose expansion part. In the dose escalation part of this study, participants will receive one of three different doses of the study drug DZ-002: 5 mg/kg, 6 mg/kg, or 7 mg/kg. Participants will receive the study drug intravenously (into a vein) over a 4-hour period on Days 1, 8, 15, and 22 of a 4-week period. This 4-week period (28 days) is referred to as a cycle.

The first 3 to 6 participants taking part in this study will get the lowest dose of 5 mg/kg. If the drug does not cause worrisome side effects, the next group of 3 to 6 participants in the study will get a higher dose of 6 mg/kg. If the drug does not cause worrisome side effects, the last group of 3 to 6 participants will receive the highest dose of 7 mg/kg. The investigator will watch each group carefully as they increase the dose. The dose will increase for each group until participants have worrisome side effects that require the dose to be lower. Once the highest dose with manageable side effects is found, the dose escalation is stopped.

In the dose expansion part of this study, the highest dose with manageable side effects will be given to 30 more participants. This will help the investigators better understand the side effects that may happen with this drug.

Participation in this study is divided into different visits:

  1. Screening Visits
  2. Treatment Visits
  3. End of Treatment Visits
  4. Post-Treatment Visits

Various tests are run during each of these different visits as described below:

  • Collection of medical history and current medications
  • Physical exam, height, weight, vital signs
  • Lung function tests
  • CT scans or PET scans
  • Heart function tests, such as Echocardiogram or multiple-gated acquisition
  • Electrocardiograms (ECG)
  • Blood draws for routine lab tests
  • Additional blood samples to measure the amount of study drug in blood
  • Urine collection
  • X-ray, if indicated
  • Tumor biopsy, optional
  • Pregnancy test, if applicable
Being tested
DZ-002 - 5 mg/kg, 6 mg/kg, or 7 mg/kg
Keywords
Dose Escalation Phase, Dose Maintenance Phase, Recommended Phase 2 Dose, RP2D
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DZ-002 - 5 mg/kg, 6 mg/kg, or 7 mg/kgDrug

    5 mg/kg, 6 mg/kg, or 7 mg/kg DZ-002 administered by IV over a 4-hour period, on Days 1, 8, 15, and 22 of a 4-week period, or cycle.

Study groups in NCT07344220
Study groupRoleWhat they receive
Dose Escalation PhaseExperimentalFirst 9-18 patients will be enrolled on the dose escalation portion. Starting dose: 3-6 study participants 5 mg/kg iv weekly Second dose: 3-6 study participants 6 mg/kg iv weekly Final dose: 3-6 study participants 7 mg/kg iv weekly
Receives: Drug: DZ-002 - 5 mg/kg, 6 mg/kg, or 7 mg/kg
Maintenance PhaseExperimentalAdditional 30 patients will be enrolled and receive the RP2D from the dose escalation phase. All patients will receive the iv weekly selected RP2Dose from dose escalation portion.
Receives: Drug: DZ-002 - 5 mg/kg, 6 mg/kg, or 7 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 Dose (RP2D)

    To determine the RP2D

    Measured: Up to 28 days of last patient dosed during the escalation phase

  2. Incidence of Dose Limiting Toxicities (DLTs)

    Dose limiting toxicities refer to toxicities experienced during the first 28 days of DZ-002 treatment that have been judged to be clinically significant and related to study treatment.

    Measured: Up to 28 days

Secondary outcomes (6)

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Incidence and severity of treatment-emergent adverse events (TEAEs), as assessed by CTCAE, V5.0.

    Measured: Approximately 2 years

  2. Progression-Free Survival

    Progression-free survival is defined as the interval from first dose date of study drug (DZ-002) to the earlier of the first documentation of definitive disease progression or death from any cause; definitive disease progression is progression based on RECIST criteria v1.1.

    Measured: Until disease progression (up to 6 months)

  3. Objective Response Rate (ORR)

    Dose Expansion portion only. The Proportion of participants who achieve complete response (CR) or partial response (PR), as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: Approximately 1 year

  4. Pharmacokinetic (PK) Parameter: Cmax of DZ-002

    Cmax is defined as the maximum observed concentration of DZ-002

    Measured: Predose and up to 24 hours post dose

  5. Pharmacokinetic (PK) Parameter: Tmax of DZ-002

    To determine the time of maximum concentration (Tmax) of DZ-002

    Measured: Predose and up to 24 hours post dose

  6. Pharmacokinetic (PK) Parameter: AUC of DZ-002

    To determine the area under the curve at the end of the DZ-002 dosing

    Measured: Predose and up to 24 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start5 Mar 2026
  3. Primary completionNov 2028 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
The first 3-6 participants taking part in this study will receive the lowest dose of study drug 5mg/kg. If the study drug does not cause unmanageable side effects at the 5mg/kg dose level, the next group of 3-6 participants will receive a higher dose of study drug 6mg/kg. If the study drug does not cause unmanageable side effects at the 6mg/kg dose level, the next group of 3-6 participants will receive the highest dose of study drug 7mg/kg.
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07344220
Sponsor's protocol ID
132-25-CA
Other IDs
DZ-002-201
Acronym
DZ-002-201
Status last verified
Sep 2026
First submitted
12 Nov 2025
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DZ-002 - 5 mg/kg, 6 mg/kg, or 7 mg/kg in people with Metastatic Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Hoag Memorial Hospital Presbyterian 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 16 inclusion and 17 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: enrolling by invitation, as of the sponsor's last update on 23 Sep 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Recommended Phase 2 Dose (RP2D) (time frame: Up to 28 days of last patient dosed during the escalation phase). 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?

On the ClinicalTrials.gov record for NCT07344220.

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 23 Sep 2026.

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