An Open-label, Multicenter Phase Ib/II Clinical 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
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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\
• 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.
Locations
Other Locations
China
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
West China Hospital of Sichuan University
RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Dermatology Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Shandong Cancer Hospital
RECRUITING
Jinan
Yunnan Cancer Hospital
RECRUITING
Kunming
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital
RECRUITING
Nanning
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Tianjin Medical University Cancer Institute &Hospital
NOT_YET_RECRUITING
Tianjin
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi’an
Contact Information
Primary
Yu Chen
maxy@leadsbiolabs.com
025-83378099
Time Frame
Start Date:2025-09-05
Estimated Completion Date:2027-12-30
Participants
Target number of participants:200
Treatments
Experimental: LBL-024
Cohort 1 (LBL-024 monotherapy):~Subjects received treatment with LBL-024 , intravenous infusion.
Experimental: LBL-024 + LBL-007 combination
Cohort 2 (LBL-024 + LBL-007 combination):~Subjects received treatment with LBL-024 combined with LBL-007 , intravenous infusion.
Experimental: LBL-024 + toripalimab combination
Cohort 3 (LBL-024 + toripalimab combination ):~Subjects received treatment with LBL-024 combined with toripalimab , both intravenous infusion.