A Study of the Treatment of Disitamab Vedotin in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Launched by SUN YAT-SEN UNIVERSITY · Jan 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Disitamab Vedotin for patients with advanced pancreatic cancer that cannot be surgically removed. The goal is to see how effective and safe this treatment is for individuals whose cancer expresses a protein called HER2. The trial is currently not recruiting participants, but it is open to adults aged 18 and older, regardless of gender, who have been diagnosed with locally advanced or metastatic pancreatic cancer. To qualify, participants need to have had specific previous treatments, show certain characteristics in their tumors, and have a good level of fitness.

If you or someone you know is interested in participating, it’s important to know that participants will need to agree to certain health criteria, including having measurable cancer lesions and good organ function. However, those with certain health conditions, like active infections or a history of immune system issues, may not be eligible. Participants will undergo regular monitoring and will be closely observed throughout the study to ensure their safety. This trial represents a hopeful step forward in finding new treatment options for pancreatic cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18 (inclusive) or above, regardless of gender.
• • 2. histologically or cytologically confirmed patients with locally advanced or metastatic pancreatic cancer who cannot undergo radical surgery
• • 3. HER2 expressing(Immunohistochemical IHC 1+,2+ or 3+)
• • 4. Number of treatment lines: Cohort 1: Prior first-line gemcitabine-free regimen or intolerant to gemcitabine-containing regimen; Cohort 2: Previous treatment with second-line standard or intolerance
• • 5. Patients who have previously received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or chemoradiotherapy for the purpose of curing non-metastatic disease must have a disease-free interval of 6 months from the last chemotherapy and/or radiotherapy to the random date
• • 6. There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.
• • 7. ECOG fitness status score: 0 or 1 point.
• • 8. Estimated survival time ≥ 3 months.
• • 9. Adequate organ function.
• • 10. Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
• • 11. Voluntary agreement to provide written informed consent.
• Exclusion Criteria:
• • 1. Central nervous system metastasis or meningeal metastasis with clinical symptoms.
• • 2. Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
• • 3. Active hepatitis B (hepatitis B virus titer\>1000 copies/ml or 200 IU/ml); Hepatitis C virus and syphilis infection.
• • 4. Have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug.
• • 5. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
• • 6. Strong inducers and inhibitors of P-gp, a strong or moderate inducer of CYP3A4, used within 14 days prior to the first use of the study drug