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

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eucure (Beijing) Biopharma Co., Ltd
• Treatments: Paclitaxel; Pembrolizumab

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.