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

Eucure (Beijing) Biopharma Co., Ltd12 sites in 1 country20 target enrollmentJune 13, 2022

ConditionsMucosal Melanoma

InterventionsYH003 Pembrolizumab albumin paclitaxel

DrugsYH003 Pembrolizumab albumin paclitaxel

Overview

Phase: Phase 2
Intervention: YH003
Conditions: Mucosal Melanoma
Sponsor: Eucure (Beijing) Biopharma Co., Ltd
Enrollment: 20
Locations: 12
Primary Endpoint: Confirmed Objective Response Rate (ORR)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 13, 2022

End Date

March 4, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eucure (Beijing) Biopharma Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1.Subjects must have the ability to understand and willingness to sign a written informed consent document.
•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;
•Subject must have at least 1 unidimensional measurable disease by RECIST 1.1;
•Subjects must be age 18 years or older;
•Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•Life expectancy ≥3 months based on investigator's judgement；
•Subjects must have adequate organ function;
•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;
•Subjects must not have a known or suspected history of autoimmune disease within 3 years prior to the first dose of study treatment;
•Subjects have clinically uncontrolled diseases;
•Subjects have severe cardiovascular disease;