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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05420324
Other study ID # YH003006
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 13, 2022
Est. completion date September 2025

Study information

Verified date June 2022
Source Eucure (Beijing) Biopharma Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 43
Est. completion date September 2025
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
YH003
YH003 will be administered intravenously over 30 minutes every 21-day cycle.
Pembrolizumab
Pembrolizumab will be administered intravenously over 30 minutes every 21-day cycle.
albumin paclitaxel
Albumin paclitaxel will be administered intravenously over 30 minutes every 21-day cycle.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Eucure (Beijing) Biopharma Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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