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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Gemcitabine; Drug: Disitamab Vedotin

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.

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dong sheng Zhang, PhD; Phone Number: 86-020-87342479; Email: zhangdsh@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Disitamab Vedotin combined with Gemcitabine，2L; Disitamab Vedotin 2.5 mg/kg，iv，Q3W; Gemcitabine 1g/m2，iv，d1, d8 Q3W; Disitamab Vedotin+Gemcitabine is used as second-line treatment for HER2-expressive patients who have failed first-line gemcitabine-free regimen or are intolerant to gemcitabine-containing regimen.	Drug: Gemcitabine; Gemcitabine; Drug: Disitamab Vedotin; Disitamab Vedotin; Other Names: RC48
Experimental: Disitamab Vedotin，3L; Disitamab Vedotin 2.5 mg/kg，iv，Q3W; Disitamab Vedotin in HER2-expressive patients who have failed at second-line standard treatment or are intolerant	Drug: Disitamab Vedotin; Disitamab Vedotin; Other Names: RC48

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Object Response Rate, ORR	Defined as the percentage of participants with a complete response (CR) or partial response (PR)	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AE)	NCI-CTCAE v5.0	up to 12 months
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
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
Over Survival, OS	Defined as time from randomization until the date of death due to any cause.	up to 12 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Dong sheng Zhang, PhD, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China

Study record dates

Study Major Dates

• Study Start (Estimated): April 17, 2024
• Primary Completion (Estimated): April 17, 2025
• Study Completion (Estimated): April 17, 2026

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Immunoconjugates; Gemcitabine; Disitamab vedotin
• Other Study ID Numbers: M01-RC48

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No