Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06010303 | A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma | PHASE2 | COMPLETED | 118 | — | — | Nov 8, 2023 | May 7, 2026 | May 28, 2026 | 38 | China, South Korea +2 |
Percentage of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| LBL-007 | EXPERIMENTAL | LBL-007 in combination with tislelizumab plus chemotherapy doublet. |
| Tislelizumab and Chemotherapy | ACTIVE_COMPARATOR | Tislelizumab plus chemotherapy doublet. |
| Name | Type | Description |
|---|---|---|
| LBL-007 | DRUG | LBL-007 will be administered at a standard dose intravenously. |
| Tislelizumab | DRUG | Tislelizumab will be administered at a standard dose intravenously. |
| Chemotherapy Doublet | DRUG | Doublet 1: cisplatin + 5-fluorouracil Doublet 2: cisplatin + paclitaxel Choice of chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously. |
Inclusion Criteria: * Able to provide written informed consent and can agree to comply with the study requirements. * Participants with metastatic ESCC or unresectable, locally advanced ESCC. * Histologically confirmed diagnosis of ESCC. * Can provide a tumor sample. * At least 1 measurable lesion ...