Actively Recruiting
An Open-label, Multicenter Phase Ib/II Study Evaluating LBL-024 Alone or Combined With LBL-007 or Toripalimab in Advanced Melanoma
Led by Nanjing Leads Biolabs Co.,Ltd · Updated on 2026-05-18
200
Participants Needed
15
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of LBL-024 alone and in combination with LBL-007 or toripalimab in patients with advanced melanoma. This open-label, multicenter study includes Phase Ib and Phase II sections to explore different dosing regimens and treatment combinations in various melanoma subtypes. The study aims to better understand how these treatments work for this serious skin cancer. The study has three treatment groups in Phase Ib: one receiving LBL-024 alone, another receiving LBL-024 combined with LBL-007, and a third receiving LBL-024 combined with toripalimab. Phase II includes a randomized part for cutaneous, acral, and unknown primary melanoma and a single-arm extension for mucosal melanoma, selecting the best combination from Phase Ib results. Treatments are given by intravenous infusion. Participants will provide samples for testing and undergo regular assessments including monitoring for side effects and evaluating tumor response. Researchers will measure outcomes such as adverse events, response rates, and progression-free survival during and after treatment, with follow-up extending up to 90 days after drug withdrawal. The study plans to enroll up to 200 subjects until late 2027.
CONDITIONS
Brief Title
A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to follow the trial treatment, visit schedule, lab tests, and protocol requirements, and sign informed consent.
- Age 18 years or older at consent, any gender.
- Eastern Cooperative Oncology Group physical status score of 0 or 1.
- Expected survival time of at least 12 weeks.
- At least one measurable tumor lesion according to RECIST 1.1.
- Willingness to use effective contraception from consent until 6 months after last study drug dose for males and females of childbearing potential.
You will not qualify if you...
- Received live vaccination within 4 weeks before first dose or planned during study and 4 weeks after.
- Major surgery or treatment impacting health within 4 weeks before first dose.
- Active autoimmune disease or history with risk of recurrence.
- History of severe cardiovascular or cerebrovascular disease.
- Active infectious disease.
- History of mental illness affecting informed consent, drug abuse, alcoholism, or addiction.
- Pregnant or breastfeeding women.
- Other conditions deemed by investigator to affect study compliance or suitability.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive intravenous infusions of LBL-024 alone or combined with LBL-007 or toripalimab as part of their assigned cohort to treat advanced melanoma.
Regular visits for treatment and monitoring as scheduled by the study team
Duration - Up to 90 days after drug withdrawal
Participants are monitored for safety and response after stopping treatment, including assessment of adverse events and tumor response.
Visits as needed for safety and efficacy assessments during follow-up period
Trial Site Locations
Total: 15 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
3
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510080
Not Yet Recruiting
4
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530200
Actively Recruiting
5
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
6
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210009
Actively Recruiting
7
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Not Yet Recruiting
8
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
9
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
10
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Actively Recruiting
11
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710004
Not Yet Recruiting
12
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
13
Tianjin Medical University Cancer Institute &Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
14
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Actively Recruiting
15
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Not Yet Recruiting
Research Team
Y
Yu Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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