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

Sponsor
Eucure (Beijing) Biopharma Co., Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05420324
Collaborator
(none)
43
Enrollment
12
Locations
1
Arm
39
Anticipated Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
43 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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: YH003
YH003 will be administered intravenously over 30 minutes every 21-day cycle.

Drug: Pembrolizumab
Pembrolizumab 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.

Outcome Measures

Primary Outcome Measures

  1. Confirmed Objective Response Rate (ORR) [up to 2 years]

    Overall Response Rate (ORR) by investigator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

    1. 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;

    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) performance status 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 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;

    1. Subjects must not have a known or suspected history of autoimmune disease within 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 2 weeks prior to the first dose.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cancer Hospital of Fujian Fuzhou Fujian China
2 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510000
3 Cancer Hospital of Zhenzhou Zhengzhou Henan China
4 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China
5 Hunan Cancer Hospital Changsha Hunan China
6 The First Hospital of Jilin University Jilin Jilin China
7 The First affiliated Hospital of Dalian Medical University Dalian Liaoning China
8 Nanjing Drum Tower Hospital Nanjing Nanjing China
9 West China Hospital of Sichuan University Chengdu Sichuan China
10 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China
11 Yunnan Cancer Hospital Kunming Yunnan China
12 Cancer Hospital of The University of Chinese Academy of Sciences Hangzhou Zhenjiang China

Sponsors and Collaborators

  • Eucure (Beijing) Biopharma Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eucure (Beijing) Biopharma Co., Ltd
ClinicalTrials.gov Identifier:
NCT05420324
Other Study ID Numbers:
  • YH003006
First Posted:
Jun 15, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Melanoma
Paclitaxel
Pembrolizumab

Study Results

No Results Posted as of Jun 15, 2022