NCT04640545CompletedPhase 1
A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma
A Phase I Multi-center Study to Evaluate the Safety ,Tolerability and Efficacy of LBL-007 Combined With Toripalimab or LBL-007 Combined With Toripalimab and Axitinib Tablets in the Treatment of Unresectable or Metastatic Melanoma
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
A phase I clinical study evaluating LBL-007 in the treatment of subjects with advanced solid tumors
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 79 (actual)
- First submitted
- 9 Nov 2020
- Start date
- 12 May 2020
- Primary completion date
- 19 Aug 2024
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Diseases
- Melanoma
- NCT number
- NCT04640545
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 79
- From 12 May 2020 to the primary completion date, 19 Aug 2024
- 7 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 with active central nervous system metastases (regardless of whether they have received treatment), including symptomatic brain metastases, meningeal metastases, or spinal cord compression, but asymptomatic brain metastases (no progression and/or at least 4 weeks after radiotherapy) No neurological symptoms or signs after surgical resection, and dexamethasone or mannitol treatment is not required);
- Have received major surgery within 4 weeks before the first administration;
Other illness
- Subjects are allergic to LBL-007, PD-1 and similar compounds or any component in the prescription;
- Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding);
Other
- Women during pregnancy or lactation;
Who the study is looking for
- Willingness to provide written informed consent and follow the study treatment plan and visit plan;
- Aged ≥ 18 years at time of signing informed consent, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1;
- Have life expectancy of at least 12 weeks ;
- Subject with at least one measurable tumor lesion,according to the evaluation standard of solid tumor efficacy (RECIST 1.1).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.