Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LBL-007
Alcestobart · 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.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (SAE) was any untoward medical occurrence that, at any dose- * resulted in death, * was life threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, * was a congenital anomaly/birth defect.
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 occured 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: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine | EXPERIMENTAL | Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent. |
| Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine | EXPERIMENTAL | Participants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen). |
| Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine | EXPERIMENTAL | Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen). |
| Phase 2: Arm A:PD-L1-positive: Alcestobart High Dose +Tislelizumab + Bevacizumab +Fluoropyrimidine | EXPERIMENTAL | PD-L1 (programmed cell death protein ligand-1)-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen). |
| Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine | EXPERIMENTAL | PD-L1-positive participants received alcestobart high dose, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen). |
| Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine | ACTIVE_COMPARATOR | PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen). |
| Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine | EXPERIMENTAL | PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen). |
| Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine | ACTIVE_COMPARATOR | PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen). |
| 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. |
| Alcestobart | DRUG | Administered intravenously (IV) at one of the following doses * Low dose: 150 mg once every 3 weeks * Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks * High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks |
| Bevacizumab or Bevacizumab biosimilar | DRUG | Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks. |
| Fluoropyrimidine (FP) | DRUG | Fluoropyrimidine treatment included one of the following: \- Capecitabine 850 mg/m\^2 administered orally twice daily for the first 2 weeks of each 3-week cycle, OR \- 5-fluorouracil (5-FU) 1600 to 2400 mg/m\^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks. |
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 ...
Alcestobart is an investigational biologic being studied for unresectable or metastatic microsatellite stable/mismatch repair proficient colorectal cancer, a form of colorectal cancer that is not biomarker selected for mismatch repair deficiency. It is being evaluated in combination with tislelizumab, bevacizumab, and fluoropyrimidine in a Phase 1/2 study.
Alcestobart is developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company is running the clinical program for the drug in colorectal cancer, including a study conducted across the United States, Australia, China, and Puerto Rico.
Alcestobart is in Phase 1/2 clinical development. It is investigational and is being tested in a single active trial that is currently active but not recruiting, with a planned enrollment of 113 participants. No completed trials of Alcestobart are listed.
Alcestobart is being studied in trial NCT05609370, a Phase 1/Phase 2 study of Alcestobart (LBL-007) plus tislelizumab in combination with bevacizumab plus fluoropyrimidine versus bevacizumab plus fluoropyrimidine in participants with unresectable or metastatic colorectal cancer. The trial is randomized and active controlled, enrolling adults 18 years and older of all sexes.
Yes, Alcestobart is also known as LBL-007. The Phase 1/Phase 2 trial NCT05609370 refers to the drug as Alcestobart (LBL-007), confirming that the two names identify the same investigational biologic being studied in unresectable or metastatic microsatellite stable/mismatch repair proficient colorectal cancer.
No. Alcestobart is investigational and remains in Phase 1/2 clinical development for unresectable or metastatic microsatellite stable/mismatch repair proficient colorectal cancer. Its only listed trial, NCT05609370, is active but not recruiting, and no completed trials of the drug are recorded.