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. 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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
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.
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Recommended Phase 2 Dose (RP2D)
To determine the RP2D
Time frame: Up to 28 days of last patient dosed during the escalation phase
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.
Time frame: Up to 28 days
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs), as assessed by CTCAE, V5.0.
Time frame: Approximately 2 years
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.
Time frame: Until disease progression (up to 6 months)
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.
Time frame: Approximately 1 year
Pharmacokinetic (PK) Parameter: Cmax of DZ-002
Cmax is defined as the maximum observed concentration of DZ-002
Time frame: Predose and up to 24 hours post dose
Pharmacokinetic (PK) Parameter: Tmax of DZ-002
To determine the time of maximum concentration (Tmax) of DZ-002
Time frame: Predose and up to 24 hours post dose
Pharmacokinetic (PK) Parameter: AUC of DZ-002
To determine the area under the curve at the end of the DZ-002 dosing
Time frame: Predose and up to 24 hours post dose
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