To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of the Treatment of Disitamab Vedotin in Patients With Locally Advanced or Metastatic Pancreatic Cancer
NCT ID:
NCT06233864
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Gemcitabine
Disitamab vedotin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Disitamab Vedotin
Description:
Disitamab Vedotin
Arm group label:
Disitamab Vedotin combined with Gemcitabine，2L
Arm group label:
Disitamab Vedotin，3L
Other name:
RC48
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine
Arm group label:
Disitamab Vedotin combined with Gemcitabine，2L
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 17, 2024
Completion date:
April 17, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06233864
