Status:
COMPLETED
A Study to Assess YH003 in Combination with Pebolizumab and Albumin Paclitaxel Injection in Subjects with Unresectable/metastatic Mucosal Melanoma
Lead Sponsor:
Eucure (Beijing) Biopharma Co., Ltd
Conditions:
Mucosal Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 patien...
Eligibility Criteria
Inclusion
- 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;
- 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
- Subjects have another active invasive malignancy within 5 years；
- 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;
- Subjects with a history of ≥ Grade 3 immune-related adverse events resulted from previous immunotherapy.
- History of clinically significant sensitivity or allergy ；
- Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.；
- History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease；
- 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；
- 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.
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05420324
Start Date
June 13 2022
End Date
March 4 2024
Last Update
January 6 2025
Active Locations (12)
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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