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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 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.
2. At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
4. The expected survival time is at least 12 weeks.
5. According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours）, the subjects enrolled have at least one measurable neoplasm lesion.
6. 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:
1. 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.
2. Major surgery or other treatment or diagnosis that has a significant impact on the subject within 4 weeks before the first dose.
3. Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.
4. History of severe cardiovascular and cerebrovascular disorder.
5. Active infectious disease.
6. History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
7. Women during pregnancy or lactation.
8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
Primary outcome measure(s)
Occurrence of adverse event (AE) and serious adverse event (SAE) — From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy) Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 monotherapy or combination therapy will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.
Objective Response Rate (ORR) — From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) According to the evaluation criteria of RECIST V1.1 (solid tumour) ,Proportion of subjects achieving complete response (CR) or partial response (PR).It was used to evaluate the efficacy in Phase Ib.
Progression-free Survival(PFS) — From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from first dose to disease progression or death from any cause.It was used to evaluate Time of disease no-progression or Drug resistance in Phase II.
Trial sites (15)
Facility
City
Region
Status
Fujian Cancer Hospital
Fuzhou
Fujian
Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
Dermatology Hospital of Southern Medical University
Guangzhou
Guangdong
Not Yet Recruiting
Guangxi Medical University Cancer Hospital
Nanning
Guangxi
Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Recruiting
Nanjing Drum Tower Hospital
Nanjing
Jiangsu
Recruiting
The First Hospital of Jilin University
Changchun
Jilin
Not Yet Recruiting
Shandong Cancer Hospital
Jinan
Shandong
Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
Not Yet Recruiting
Shanxi Bethune Hospital
Taiyuan
Shanxi
Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an
Shanxi
Not Yet Recruiting
West China Hospital of Sichuan University
Chengdu
Sichuan
Recruiting
Tianjin Medical University Cancer Institute &Hospital
Tianjin
Tianjin Municipality
Not Yet Recruiting
Yunnan Cancer Hospital
Kunming
Yunnan
Recruiting
Zhejiang Cancer Hospital
Hangzhou
Zhejiang
Not Yet Recruiting
More Nanjing Leads Biolabs Co.,Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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