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

October 8, 2022 updated by: Eucure (Beijing) Biopharma Co., Ltd

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Cancer Hospital of Fujian
        • Contact:
          • ling chen
          • Phone Number: 13960828743
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Cancer Hospital of Zhenzhou
        • Contact:
          • yan wang
          • Phone Number: 13592691213
    • Hubei
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jilin
      • Jilin, Jilin, China
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China
        • Not yet recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
          • jiwei liu
          • Phone Number: 18098877966
    • Nanjing
      • Nanjing, Nanjing, China
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
          • lianjun zhao
          • Phone Number: 15951956162
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China
        • Not yet recruiting
        • Yunnan Cancer Hospital
        • Contact:
    • Zhenjiang
      • Hangzhou, Zhenjiang, China
        • Not yet recruiting
        • Cancer Hospital of The University of Chinese Academy of Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: up to 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Eucure (Beijing) Biopharma Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

September 1, 2025

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)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YH003006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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