A Trial of LBL-024 Monotherapy or Combination With Toripalimab in Patients With Advanced Melanoma.
- Summary
- This study is an open-label, multicenter phase Ib/II study to evaluate the efficacy and safety of LBL-024 monotherapy or combination with 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.
- Short title
- A Trial of LBL-024 Monotherapy or Combination With Toripalimab in Patients With Advanced Melanoma.
- Official title
- An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 Monotherapy or Combination With Toripalimab in Patients With Advanced Melanoma.
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2027-12-30
- First posted
- 2025-08-01
- Registry last updated
- 2026-10-21
- Primary completion date
- 2027-10-30
- Start date
- 2025-09-05
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07099430
- ClinicalTrials.gov ID
- NCT07099430
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Occurrence of adverse event (AE) and serious adverse event (SAE)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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.
Cmax
Timeframe: 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)
Maximum drug concentration in plasma after administration.
Tmax
Timeframe: 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)
After administration,Time to reach maximum drug concentration in plasma.
Immunogenicity
Timeframe: 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)
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.Immunogenicity refers to the performance that can elicit an immune response.
Disease Control Rate(DCR)
Timeframe: 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)
Percentage of participants achieving CR, PR, iCR, iPR and stable disease (SD) after treatment.
Duration of Response(DOR)
Timeframe: 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)
DOR is defined as the duration from earliest date of disease response (CR、PR 、iCR or iPR) until earliest date of disease progression or death from any cause(if occurring sooner than progression).
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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 participant 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 participant has other conditions that may affect compliance or are not suitable for participating in this study.
- Beijing GoBroad HospitalBeijing, ChinaNot yet recruiting
- Fujian Cancer HospitalFuzhou, ChinaRecruiting
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaRecruiting
- Dermatology Hospital of Southern Medical UniversityGuangzhou, ChinaNot yet recruiting
- Guangxi Medical University Cancer HospitalNanning, ChinaRecruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaRecruiting
- Nanjing Drum Tower HospitalNanjing, ChinaRecruiting
- The First Hospital of Jilin UniversityChangchun, ChinaRecruiting
- Shandong Cancer HospitalJinan, ChinaRecruiting
- Fudan University Shanghai Cancer CenterShanghai, ChinaNot yet recruiting
- Shanxi Bethune HospitalTaiyuan, ChinaRecruiting
- The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaNot yet recruiting
- West China Hospital of Sichuan UniversityChengdu, ChinaRecruiting
- Tianjin Medical University Cancer Institute &HospitalTianjin, ChinaNot yet recruiting
- Yunnan Cancer HospitalKunming, ChinaRecruiting
- Zhejiang Cancer HospitalHangzhou, ChinaNot yet recruiting
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Melanoma Primary condition