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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06233864
• Other study ID #: M01-RC48
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 17, 2024
• Est. completion date: April 17, 2026

Study information

• Verified date: February 2024
• Source: Sun Yat-sen University
• Contact: Dong sheng Zhang, PhD
• Phone: 86-020-87342479
• Email: zhangdsh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: April 17, 2026
• Est. primary completion date: April 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Disitamab Vedotin
Disitamab Vedotin
• Gemcitabine
Gemcitabine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Object Response Rate, ORR	Defined as the percentage of participants with a complete response (CR) or partial response (PR)	up to 12 months
Secondary	Disease Control Rate, DCR	Defined as the proportion of participants who have a complete response (CR), partial response (PR) or standard disease (SD) as assessed by investigator according to RECIST 1.1	up to 12 months
Secondary	Progress Free Survival, PFS	Defined as time from randomization until progression per RECIST 1.1 as assessed by investigator, or death due to any cause.	up to 12 months
Secondary	Over Survival, OS	Defined as time from randomization until the date of death due to any cause.	up to 12 months
Secondary	Adverse Events (AE)	NCI-CTCAE v5.0	up to 12 months