A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma
Recruiting · NCT07099430 · Interventional (participants receive a specific treatment) · Lead sponsor: Nanjing Leads Biolabs Co.,Ltd
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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 it is running
15 locations listed.
- Fujian Cancer Hospital - Fuzhou, Fujian, China
- Sun Yat-sen University Cancer Center - Guangzhou, Guangdong, China
- Dermatology Hospital of Southern Medical University - Guangzhou, Guangdong, China
- Guangxi Medical University Cancer Hospital - Nanning, Guangxi, China
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hubei, China
- Nanjing Drum Tower Hospital - Nanjing, Jiangsu, China
- The First Hospital of Jilin University - Changchun, Jilin, China
- Shandong Cancer Hospital - Jinan, Shandong, China
- Fudan University Shanghai Cancer Center - Shanghai, Shanghai Municipality, China
- Shanxi Bethune Hospital - Taiyuan, Shanxi, China
- The Second Affiliated Hospital of Xi'an Jiaotong University - Xi’an, Shanxi, China
- West China Hospital of Sichuan University - Chengdu, Sichuan, China
- Tianjin Medical University Cancer Institute &Hospital - Tianjin, Tianjin Municipality, China
- Yunnan Cancer Hospital - Kunming, Yunnan, China
- Zhejiang Cancer Hospital - Hangzhou, Zhejiang, China