A Study to Assess YH003 in Combination with Pebolizumab and Albumin Paclitaxel Injection in Subjects with Unresectable/metastatic Mucosal Melanoma

Last updated: January 3, 2025
Sponsor: Eucure (Beijing) Biopharma Co., Ltd
Overall Status: Completed

Phase

2

Condition

Melanoma

Treatment

albumin paclitaxel

YH003

Pembrolizumab

Clinical Study ID

NCT05420324
YH003006
  • Ages > 18
  • All Genders

Study Summary

This study is a multicenter, single-arm, open-label phase II study to assess the efficacy and safety of YH003 in combination with pembrolizumab and nab-paclitaxel in the first-line treatment of patients with unresectable/metastatic mucosal melanoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.Subjects must have the ability to understand and willingness to sign a writteninformed consent document.

  1. Subjects must have histologically advanced or cytologically confirmedmetastatic or unresectable mucosal melanoma;
  • 3.Subjects have not received standard systemic therapy; patients have diseaseprogression 6 months or more after the end of neoadjuvant or adjuvant therapy (except nab-paclitaxel), and can be enrolled in the clinical study;

  1. Subject must have at least 1 unidimensional measurable disease by RECIST 1.1;
  1. Subjects must be age 18 years or older;
  1. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performancestatus of 0 or 1.
  1. Life expectancy ≥3 months based on investigator's judgement;
  1. Subjects must have adequate organ function;
  1. Women of childbearing potential need to have a negative pregnancy test and needto take contraceptive/contraceptive measures including their partners.

Exclusion

Exclusion Criteria:

  • 1.Subjects have another active invasive malignancy within 5 years;

  • 2.The subject has received anti-tumor therapy or other investigational drug therapyor traditional Chinese medicine (herbal medicine) with anti-tumor indications priorto the first dose;

  • 3.Subjects with a history of ≥ Grade 3 immune-related adverse events resulted fromprevious immunotherapy.

  • 4.History of clinically significant sensitivity or allergy ;

  • 5.Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.;

  • 6.History of (non-infectious) pneumonitis that required corticosteroids or currentpneumonitis, or history of interstitial lung disease;

  • 7.Subjects have active pulmonary embolism with hemodynamic changes 12 weeks beforethe first dose;

  1. Subjects must not have a known or suspected history of autoimmune diseasewithin 3 years prior to the first dose of study treatment;
  1. Subjects have clinically uncontrolled diseases;
  1. Subjects have severe cardiovascular disease;
  1. Subjects have evidence of active infection;
  1. Subjects must not have a known or suspected history of an autoimmune disorder;
  • 13.Major surgery within 4 weeks prior to study entry and Minor surgery within 2weeks prior to the first dose.

  1. Any condition that the investigator assesses as inappropriate for participationin the study.

Study Design

Total Participants: 20
Treatment Group(s): 3
Primary Treatment: albumin paclitaxel
Phase: 2
Study Start date:
June 13, 2022
Estimated Completion Date:
March 04, 2024

Connect with a study center

  • Cancer Hospital of Fujian

    Fuzhou, Fujian
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Cancer Hospital of Zhenzhou

    Zhengzhou, Henan
    China

    Site Not Available

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan
    China

    Site Not Available

  • The First Hospital of Jilin University

    Jilin, Jilin
    China

    Site Not Available

  • The First affiliated Hospital of Dalian Medical University

    Dalian, Liaoning
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Nanjing
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • Yunnan Cancer Hospital

    Kunming, Yunnan
    China

    Site Not Available

  • Cancer Hospital of The University of Chinese Academy of Sciences

    Hangzhou, zhenjiang
    China

    Site Not Available

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