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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05420324
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eucure (Beijing) Biopharma Co., Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Mucosal Melanoma
Arms & Interventions

Arms

Experimental: Intervention/treatment

YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma

Interventions

Drug: - YH003

YH003 will be administered intravenously over 30 minutes every 21-day cycle.

Drug: - Pembrolizumab

Pembrolizumab will be administered intravenously over 30 minutes every 21-day cycle.

Drug: - albumin paclitaxel

Albumin paclitaxel will be administered intravenously over 30 minutes every 21-day cycle.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Cancer Hospital of Fujian, Fuzhou, Fujian, China

Status

Not yet recruiting

Address

Cancer Hospital of Fujian

Fuzhou, Fujian,

Site Contact

ling chen

13960828743

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000

Site Contact

ya ding

[email protected]

13824454838

Cancer Hospital of Zhenzhou, Zhengzhou, Henan, China

Status

Not yet recruiting

Address

Cancer Hospital of Zhenzhou

Zhengzhou, Henan,

Site Contact

yan wang

13592691213

Wuhan, Hubei, China

Status

Not yet recruiting

Address

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei,

Site Contact

li fan

[email protected]

15927574289

Hunan Cancer Hospital, Changsha, Hunan, China

Status

Recruiting

Address

Hunan Cancer Hospital

Changsha, Hunan,

Site Contact

xingxiang pu

[email protected]

15874180022

The First Hospital of Jilin University, Jilin, Jilin, China

Status

Not yet recruiting

Address

The First Hospital of Jilin University

Jilin, Jilin,

Site Contact

zhen guo

[email protected]

15843073215

Dalian, Liaoning, China

Status

Not yet recruiting

Address

The First affiliated Hospital of Dalian Medical University

Dalian, Liaoning,

Site Contact

jiwei liu

18098877966

Nanjing Drum Tower Hospital, Nanjing, Nanjing, China

Status

Not yet recruiting

Address

Nanjing Drum Tower Hospital

Nanjing, Nanjing,

Site Contact

lianjun zhao

15951956162

Chengdu, Sichuan, China

Status

Not yet recruiting

Address

West China Hospital of Sichuan University

Chengdu, Sichuan,

Site Contact

yu jiang

[email protected]

18980601130

Tianjin, Tianjin, China

Status

Recruiting

Address

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin,

Site Contact

xiubao ren

[email protected]

13820602901

Yunnan Cancer Hospital, Kunming, Yunnan, China

Status

Not yet recruiting

Address

Yunnan Cancer Hospital

Kunming, Yunnan,

Site Contact

chunlei ge

[email protected]

18980601130

Hangzhou, Zhenjiang, China

Status

Not yet recruiting

Address

Cancer Hospital of The University of Chinese Academy of Sciences

Hangzhou, Zhenjiang,

Site Contact

meiyu fang

[email protected]

13750851650

Stay Informed & Connected