Clinical trial · Interventional
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
NCT04640545CI-TRIAL-00111377completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A phase I clinical study evaluating LBL-007 in the treatment of subjects with advanced solid tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axitinib Tablets | Drug | Axitinib | ALIAS |
| LBL-007 | Drug | — | UNRESOLVED |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LBL-007+Toripalimab+Axitinib Tablets
- description
- Study Part A： LBL-007 +Toripalimab Study Part B： LBL-007 +Toripalimab +Axitinib Tablets
- interventionNames
- Drug: LBL-007
- Drug: Toripalimab
- Drug: Axitinib Tablets
Primary outcomes (3)
- measure
- Number of subjcects with adverse events and serious adverse events
- timeFrame
- All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)
- description
- The safety profile of LBL-007 and Toripalimab will be assessed by monitoring the adverse event(AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE)v5.0
- measure
- Maximum tolerated dose (MTD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Willingness to provide written informed consent and follow the study treatment plan and visit plan; 2. Aged ≥ 18 years at time of signing informed consent, male or female; 3. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1; 4. Have life expectancy of at least 12 weeks ; 5. Subject with at least one measurable tumor lesion,according to the evaluation standard of solid tumor efficacy (RECIST 1.1). Exclusion criteria: 1. Subjects are allergic to LBL-007, PD-1 and similar compounds or any component in the prescription; 2. 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); 3. Have received major surgery within 4 weeks before the first administration; 4. Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding); 5. Women during pregnancy or lactation;
References
Publications (0)
Data not yet available
No reference posted for this study.