Clinical trial · Interventional
A Study to Assess YH003 in Combination with Pebolizumab and Albumin Paclitaxel Injection in Subjects with Unresectable/metastatic Mucosal Melanoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucosal Melanoma | Mucosal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| albumin paclitaxel | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| YH003 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention/treatment
- description
- YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma
- interventionNames
- Drug: YH003
- Drug: Pembrolizumab
- Drug: albumin paclitaxel
Primary outcomes (1)
- measure
- Confirmed Objective Response Rate (ORR)
- timeFrame
- up to 2 years
- description
- Overall Response Rate (ORR) by investigator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available