Clinical trial NCT06233864: A Study of the Treatment of Disitamab Vedotin in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Official title: A Phase II Clinical Study of the Treatment of Disitamab Vedotin（RC48) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Expressing HER2
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 63 patients with locally advanced or metastatic pancreatic cancer will participate in this study. HER2 expression in locally advanced or metastatic pancreatic cancer patients is defined as the expression of HER2 in tumor tissues detected by immunohistochemistry (IHC) as IHC 1+, 2+, or 3+. The arm 1 recruits 43 patients and the arm 2 recruits 20 patients.

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

Primary outcomes:
measure: Object Response Rate, ORR
timeFrame: up to 12 months
Secondary outcomes:
measure: Disease Control Rate, DCR
timeFrame: up to 12 months
measure: Progress Free Survival, PFS
timeFrame: up to 12 months
measure: Over Survival, OS
timeFrame: up to 12 months
measure: Adverse Events (AE)
timeFrame: up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China
name: Dong sheng Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: