A Phase II Clinical Study of the Treatment of Disitamab Vedotin（RC48) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Expressing HER2

Trial ID: NCT06233864

Interventional - Phase 2 - Unknown status

This is a phase 2 clinical study,to explore the efficacy and safety of Disitamab Vedotin in patients with locally advanced or metastatic pancreatic cancer expressing HER2.

Conditions

• Pancreatic Cancer

Interventions

• Disitamab Vedotin
• Gemcitabine

Eligibility

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

Sponsor

Sun Yat-sen University

Source: ClinicalTrials.gov

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