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

NCT06233864 | Not Yet Recruiting Phase 2

• 1 other identifier: M01-RC48
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Object Response Rate, ORR

  Defined as the percentage of participants with a complete response (CR) or partial response (PR)

  up to 12 months

Secondary Outcomes (4)

• Disease Control Rate, DCR

  up to 12 months

• Progress Free Survival, PFS

  up to 12 months

• Over Survival, OS

  up to 12 months

• Adverse Events (AE)

  up to 12 months

Study Arms (2)

Disitamab Vedotin combined with Gemcitabine，2L

EXPERIMENTAL

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: Disitamab Vedotin; Drug: Gemcitabine

Disitamab Vedotin，3L

EXPERIMENTAL

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

Interventions

Disitamab Vedotin DRUG

Disitamab Vedotin

Also known as: RC48

Disitamab Vedotin combined with Gemcitabine，2L; Disitamab Vedotin，3L

Gemcitabine DRUG

Gemcitabine

Disitamab Vedotin combined with Gemcitabine，2L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age: 18 (inclusive) or above, regardless of gender.
• \. histologically or cytologically confirmed patients with locally advanced or metastatic pancreatic cancer who cannot undergo radical surgery
• \. HER2 expressing(Immunohistochemical IHC 1+,2+ or 3+)
• \. 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
• \. 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
• \. There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.
• \. ECOG fitness status score: 0 or 1 point.
• \. Estimated survival time ≥ 3 months.
• \. Adequate organ function.
• \. Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
• \. Voluntary agreement to provide written informed consent.

You may not qualify if:

• \. Central nervous system metastasis or meningeal metastasis with clinical symptoms.
• \. Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
• \. Active hepatitis B (hepatitis B virus titer\>1000 copies/ml or 200 IU/ml); Hepatitis C virus and syphilis infection.
• \. Have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug.
• \. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
• \. 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

disitamab vedotin; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Dong sheng Zhang, PhD

  Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong sheng Zhang, PhD

CONTACT

86-020-87342479; zhangdsh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: April 17, 2024
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2026
• Last Updated: April 17, 2024

Record last verified: 2024-02