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 (13) 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
NOT_YET_RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Shandong Cancer Hospital
NOT_YET_RECRUITING
Jinan
Yunnan Cancer Hospital
NOT_YET_RECRUITING
Kunming
Nanjing Drum Tower Hospital
NOT_YET_RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING
Nanning
Shanxi Bethune Hospital
NOT_YET_RECRUITING
Taiyuan
Tianjin Medical University Cancer Institute &Hospital
NOT_YET_RECRUITING
Tianjin
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_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.