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

A Multicenter, Single-arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of YH003 in Combination with Pebolizumab and Albumin Paclitaxel in First-line Treatment of Patients with Unresectable/metastatic Mucosal Melanoma

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.

Study Overview

• Status: Completed
• Conditions: Mucosal Melanoma
• Intervention / Treatment: Drug: Pembrolizumab; Drug: YH003; Drug: albumin paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Cancer Hospital of Fujian
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University Cancer Center
  • Henan
    • Zhengzhou, Henan, China
      • Cancer Hospital of Zhenzhou
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital
  • Jilin
    • Jilin, Jilin, China
      • The First Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China
      • The First Affiliated Hospital of Dalian Medical University
  • Nanjing
    • Nanjing, Nanjing, China
      • Nanjing Drum Tower Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University Cancer Institute and Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • Yunnan Cancer Hospital
  • zhenjiang
    • Hangzhou, zhenjiang, China
      • Cancer Hospital of The University of Chinese Academy of Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1.Subjects must have the ability to understand and willingness to sign a written informed consent document.
• 2. Subjects must have histologically advanced or cytologically confirmed metastatic or unresectable mucosal melanoma;
• 3.Subjects have not received standard systemic therapy; patients have disease progression 6 months or more after the end of neoadjuvant or adjuvant therapy (except nab-paclitaxel), and can be enrolled in the clinical study;
• 4. Subject must have at least 1 unidimensional measurable disease by RECIST 1.1;
• 5. Subjects must be age 18 years or older;
• 6. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• 7. Life expectancy ≥3 months based on investigator's judgement；
• 8. Subjects must have adequate organ function;
• 9. Women of childbearing potential need to have a negative pregnancy test and need to take contraceptive/contraceptive measures including their partners.

Exclusion Criteria:

• 1.Subjects have another active invasive malignancy within 5 years；
• 2.The subject has received anti-tumor therapy or other investigational drug therapy or traditional Chinese medicine (herbal medicine) with anti-tumor indications prior to the first dose;
• 3.Subjects with a history of ≥ Grade 3 immune-related adverse events resulted from previous 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 current pneumonitis, or history of interstitial lung disease；
• 7.Subjects have active pulmonary embolism with hemodynamic changes 12 weeks before the first dose;
• 8. Subjects must not have a known or suspected history of autoimmune disease within 3 years prior to the first dose of study treatment;
• 9. Subjects have clinically uncontrolled diseases;
• 10. Subjects have severe cardiovascular disease;
• 11. Subjects have evidence of active infection;
• 12. 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 2 weeks prior to the first dose.
• 14. Any condition that the investigator assesses as inappropriate for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention/treatment; YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma	Drug: Pembrolizumab; Pembrolizumab will be administered intravenously over 30 minutes every 21-day cycle.; Drug: YH003; YH003 will be administered intravenously over 30 minutes every 21-day cycle.; Drug: albumin paclitaxel; Albumin paclitaxel will be administered intravenously over 30 minutes every 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed Objective Response Rate (ORR)	Overall Response Rate (ORR) by investigator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	up to 2 years

Collaborators and Investigators

• Sponsor: Eucure (Beijing) Biopharma Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Actual): March 4, 2024
• Study Completion (Actual): March 4, 2024

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Pembrolizumab; Paclitaxel
• Other Study ID Numbers: YH003006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No