A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma
About this study
This study is an open-label, multicenter phase Ib/II study to evaluate the efficacy and safety of LBL-024 monotherapy, LBL-024 in combination with LBL-007 or toripalimab in patients with advanced melanoma,To evaluate the preliminary efficacy and safety of LBL-024 monotherapy and combination therapy in patients with advanced melanoma.
- Condition
- Advanced Melanoma
- Tested
- LBL-024 for Injection, LBL-007 Injection, Toripalimab Injection
- Sponsor
- Nanjing Leads Biolabs Co.,Ltd
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: Advanced Melanoma
- Agree to follow the trial treatment regimen, visit schedule,laboratory test, and comply with other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
- At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.
- The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
- The expected survival time is at least 12 weeks.
- According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours）, the subjects enrolled have at least one measurable neoplasm lesion.
- Male of childbearing potential and Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug.
Exclusion 8
- Subjects who received live vaccination within 4 weeks before the first dose or were planned to receive live vaccination during the study period and 4 weeks after the dose.
- Major surgery or other treatment or diagnosis that has a significant impact on the subject within 4 weeks before the first dose.
- Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.
- History of severe cardiovascular and cerebrovascular disorder.
- Active infectious disease.
- History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
- Women during pregnancy or lactation.
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
Where
15 sites, 15 recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Shandong Cancer Hospital
Jinan, Shandong, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
and 9 more sites on ClinicalTrials.gov
Contact
-
Yu Chen
025-83378099 maxy@leadsbiolabs.com
Potential match only. Final eligibility is determined by the study team.