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Trial record 1 of 1 for:    yh003006
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A Study to Assess YH003 in Combination With Pebolizumab and Albumin Paclitaxel Injection in Subjects With Unresectable/Metastatic Mucosal Melanoma

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ClinicalTrials.gov Identifier: NCT05420324
Recruitment Status : Recruiting
First Posted : June 15, 2022
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Eucure (Beijing) Biopharma Co., Ltd

Study Description
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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
Mucosal Melanoma Drug: YH003 Drug: Pembrolizumab Drug: albumin paclitaxel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : June 13, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05420324


Locations
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China, Fujian
Cancer Hospital of Fujian Not yet recruiting
Fuzhou, Fujian, China
Contact: ling chen    13960828743      
China, Guangdong
Sun Yat-sen University Cancer Center Not yet recruiting
Guangzhou, Guangdong, China, 510000
Contact: ya ding    13824454838    dingya@sysucc.org.cn   
China, Henan
Cancer Hospital of Zhenzhou Not yet recruiting
Zhengzhou, Henan, China
Contact: yan wang    13592691213      
China, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China
Contact: li fan    15927574289    chenjingunion@163.com   
China, Hunan
Hunan Cancer Hospital Recruiting
Changsha, Hunan, China
Contact: xingxiang pu    15874180022    pxx_1354@163.com   
China, Jilin
The First Hospital of Jilin University Not yet recruiting
Jilin, Jilin, China
Contact: zhen guo    15843073215    wudi991202@163.com   
China, Liaoning
The First affiliated Hospital of Dalian Medical University Not yet recruiting
Dalian, Liaoning, China
Contact: jiwei liu    18098877966      
China, Nanjing
Nanjing Drum Tower Hospital Not yet recruiting
Nanjing, Nanjing, China
Contact: lianjun zhao    15951956162      
China, Sichuan
West China Hospital of Sichuan University Not yet recruiting
Chengdu, Sichuan, China
Contact: yu jiang    18980601130    jiangyuwork@126.com   
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China
Contact: xiubao ren    13820602901    xiubao_ren@126.com   
China, Yunnan
Yunnan Cancer Hospital Not yet recruiting
Kunming, Yunnan, China
Contact: chunlei ge    18980601130    jiangyuwork@126.com   
China, Zhenjiang
Cancer Hospital of The University of Chinese Academy of Sciences Not yet recruiting
Hangzhou, Zhenjiang, China
Contact: meiyu fang    13750851650    fangmy@zjcc.org.cn   
Sponsors and Collaborators
Eucure (Beijing) Biopharma Co., Ltd
More Information
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Responsible Party: Eucure (Beijing) Biopharma Co., Ltd
ClinicalTrials.gov Identifier: NCT05420324    
Other Study ID Numbers: YH003006
First Posted: June 15, 2022    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Paclitaxel
 Pembrolizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological