A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma
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
1 other identifier
interventional
200
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2025
Typical duration for phase_1
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2025
CompletedFirst Posted
Study publicly available on registry
August 1, 2025
CompletedStudy Start
First participant enrolled
September 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
December 4, 2025
September 1, 2025
2.2 years
July 25, 2025
December 2, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Occurrence of adverse event (AE) and serious adverse event (SAE)
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.
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)
Objective Response Rate (ORR)
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.
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)
Progression-free Survival(PFS)
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.
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)
Secondary Outcomes (5)
Cmax
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)
Tmax
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)
Immunogenicity
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)
Disease Control Rate(DCR)
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)
Duration of Response(DOR)
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)
Study Arms (3)
LBL-024
EXPERIMENTALCohort 1 (LBL-024 monotherapy): Subjects received treatment with LBL-024 , intravenous infusion.
LBL-024 + LBL-007 combination
EXPERIMENTALCohort 2 (LBL-024 + LBL-007 combination): Subjects received treatment with LBL-024 combined with LBL-007 , intravenous infusion.
LBL-024 + toripalimab combination
EXPERIMENTALCohort 3 (LBL-024 + toripalimab combination ): Subjects received treatment with LBL-024 combined with toripalimab , both intravenous infusion.
Interventions
LBL-024 , Intravenous infusion.
LBL-007 , intravenous infusion.
Toripalimab , intravenous infusion.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510080, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530200, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210009, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute &Hospital
Tianjin, Tianjin Municipality, 300060, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu Chen
Fujian Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2025
First Posted
August 1, 2025
Study Start
September 5, 2025
Primary Completion (Estimated)
October 30, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
December 4, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share