Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LBL-007 · 2 trials · 4 indications
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.
Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 \[NCI-CTCAE v5.0\]).
PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| LBL-007 | EXPERIMENTAL | LBL-007 in combination with tislelizumab plus chemotherapy doublet. |
| Tislelizumab and Chemotherapy | ACTIVE_COMPARATOR | Tislelizumab plus chemotherapy doublet. |
| Phase 1b: Cohort -1: LBL-007 + Tislelizumab + Bevacizumab + Capecitabine | EXPERIMENTAL | LBL-007 (low dose) + tislelizumab (low dose once every 3 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks) + capecitabine |
| Phase 1b: Cohort 1a: LBL-007 + Tislelizumab + Bevacizumab + Capecitabine | EXPERIMENTAL | LBL-007 (medium dose) + tislelizumab (low dose once every 3 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks) + capecitabine |
| Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5-Fluorouracil (5-FU) | EXPERIMENTAL | LBL-007 (medium dose) + tislelizumab (high dose once every 4 weeks) + bevacizumab (5 mg/kg once every 2 weeks) + 5-FU |
| Phase 1b: Cohort 2: LBL-007 + Tislelizumab + Bevacizumab + Fluoropyrimidine | EXPERIMENTAL | LBL-007 (high dose) + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine) |
| Phase 2: Arm A and Arm D: LBL-007 + Tislelizumab + Bevacizumab + Fluoropyrimidine | EXPERIMENTAL | LBL-007 (high dose) + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine) |
| Phase 2: Arm B: LBL-007 + Bevacizumab + Fluoropyrimidine | EXPERIMENTAL | LBL-007 (high dose) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine) |
| Phase 2: Arm C and Arm E: Bevacizumab + Fluoropyrimidine | ACTIVE_COMPARATOR | Bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine) |
| 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. |
| Bevacizumab or Bevacizumab biosimilar | DRUG | Administered intravenously |
| Capecitabine | DRUG | Administered in accordance with relevant local guidelines and/or prescribing information |
| 5-Fluorouracil | DRUG | Administered in accordance with relevant local guidelines and/or prescribing information |
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 ...
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LBL-007 is an investigational small molecule being studied for the treatment of esophageal cancer, specifically unresectable locally advanced or metastatic esophageal squamous cell carcinoma, and for unresectable or metastatic microsatellite stable/mismatch repair proficient colorectal cancer. It is currently in Phase 2 clinical development for these oncology indications.
LBL-007 targets LAG-3, a protein involved in immune regulation. By targeting LAG-3, LBL-007 is designed to modulate the immune response in cancer. It is being studied in combination with other therapies, such as tislelizumab and chemotherapy, for the treatment of esophageal and colorectal cancers.
LBL-007 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker ONC. The company is conducting clinical trials to evaluate the safety and efficacy of LBL-007 in patients with esophageal cancer and colorectal cancer.
LBL-007 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in active clinical trials for the treatment of unresectable or metastatic microsatellite stable/mismatch repair proficient colorectal cancer and esophageal squamous cell carcinoma.
LBL-007 is being studied in two clinical trials. NCT05609370 is a Phase 1 trial evaluating LBL-007 plus tislelizumab in combination with bevacizumab plus fluoropyrimidine in participants with unresectable or metastatic colorectal cancer. NCT06010303 is a Phase 2 trial evaluating LBL-007 in combination with tislelizumab plus chemotherapy in participants with esophageal squamous cell carcinoma.
No, LBL-007 is not the same as tislelizumab. LBL-007 is a small molecule that targets LAG-3, while tislelizumab is a different drug that is being studied in combination with LBL-007 in clinical trials. The two drugs have different mechanisms of action and are used together in investigational treatment regimens.