NCT07099430RecruitingPhase 1/2
A Trial of LBL-024 Monotherapy or Combination With 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 or Combination With Toripalimab in Patients With Advanced Melanoma.
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 25 Jul 2025
- Start date
- 5 Sept 2025
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Diseases
- Melanoma
- NCT number
- NCT07099430
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 280
- From 5 Sept 2025 to the primary completion date, 30 Oct 2027
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- The investigator believes that the participant has other conditions that may affect compliance or are not suitable for participating in this study.
Other
- Women during pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing GoBroad Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Dermatology Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Guangxi Medical University Cancer Hospital Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shanxi Bethune Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The Second Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.