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

Part of paid clinical trials in Newport Beach, California.

Sponsor
Hoag Memorial Hospital Presbyterian
Study ID
NCT07344220
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DZ-002 - 5 mg/kg, 6 mg/kg, or 7 mg/kg — DRUG
    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 Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Nov 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
39 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Phase
    First 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
  • Experimental: Maintenance Phase
    Additional 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.

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 28 days of last patient dosed during the escalation phase ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663-

Find similar trials in Newport Beach, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Hoag Memorial Hospital Presbyterian· Newport Beach, CA

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