Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Gimistotug
BGB-A445 · 3 trials · 9 indications
Overall response rate (ORR) is defined as the percentage of participants with best overall response (BOR) of a confirmed complete response (CR) or partial response (PR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1. CR is defined as: * Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. * Disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes must be nonpathological in size (\< 10 mm short axis). * No new lesions. PR is defined as: * At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * Non-progressive disease with regard to non-target lesions, persistence of 1 or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. * No new lesions.
ORR is defined as the percentage of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
The MTD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
| Arm | Type | Description |
|---|---|---|
| Gimistotug + Docetaxel | EXPERIMENTAL | Participants received gimistotug and docetaxel 75 mg/m\^2 both by intravenous infusion once every 3 weeks until disease progression, intolerable toxicity, withdrawal of informed consent, or other discontinuation criterion were met. |
| Gimistotug + BGB-15025 | EXPERIMENTAL | Participants received gimistotug by intravenous infusion once every 3 weeks and BGB-15025 orally once daily during each 3-week cycle until disease progression, intolerable toxicity, withdrawal of informed consent, or other discontinuation criterion were met. |
| Cohort A: Previously Treated UC | EXPERIMENTAL | BGB-A445 Monotherapy |
| Cohort B: Previously Treated UC | EXPERIMENTAL | BGB-A445 and Tislelizumab |
| Cohort C: Previously Treated RCC | EXPERIMENTAL | BGB-A445 Monotherapy |
| Cohort D: Previously Treated RCC | EXPERIMENTAL | BGB-A445 and Tislelizumab |
| Cohort E: Previously Treated Melanoma | EXPERIMENTAL | BGB-A445 Monotherapy |
| Cohort F: Previously Treated Melanoma | EXPERIMENTAL | BGB-A445 and Tislelizumab |
| Cohort G: First Line Cisplatin Ineligible UC | EXPERIMENTAL | BGB-A445 and Tislelizumab |
| Cohort H: First Line Non-mucosal Melanoma | EXPERIMENTAL | BGB-A445 and Tislelizumab |
| Cohort I: Previously Treated Non-mucosal Melanoma | EXPERIMENTAL | BGB-A445 and Tislelizumab |
| Phase 1a: BGB-A445 Monotherapy | EXPERIMENTAL | Dose Escalation Part A: Participants will receive intravenous (IV) infusion of BGB-A445 in sequential cohorts of approximately 8 increasing dose levels on day 1 of each 21-day cycle |
| Phase 1a: BGB-A445 + Tislelizumab Combination Therapy | EXPERIMENTAL | Dose Escalation Part B: Participants will receive IV infusion of BGB-A445 in sequential cohorts of approximately 6 increasing dose levels plus 200mg tislelizumab on day 1 of each 21-day cycle |
| Phase 1b:BGB-A445 Monotherapy | EXPERIMENTAL | Dose Expansion Part A: Participants will receive recommended doses of IV BGB-A445 as determined from Phase 1a Dose Escalation; BGB-A445 will be evaluated in two tumor types |
| Phase 1b: BGB-A445 + Tislelizumab and Chemotherapy Combination Therapy | EXPERIMENTAL | Dose Expansion Part B: Participants will receive recommended dose IV infusion of BGB-A445 plus 200mg tislelizumab and chemotherapy |
| Phase 1b: BGB-A445 Monotherapy | EXPERIMENTAL | Dose Expansion Part C: Participants will receive 1 dose level of BGB-A445 |
| Name | Type | Description |
|---|---|---|
| Gimistotug | DRUG | Administered intravenously |
| Docetaxel | DRUG | 75 milligrams per square meter (mg/m\^2) administered intravenously |
| BGB-15025 | DRUG | Administered orally |
| BGB-A445 | DRUG | administered intravenously |
| Tislelizumab | DRUG | administered intravenously |
Inclusion Criteria: * Advanced or metastatic NSCLC (nonsquamous or squamous) that is histologically or cytologically confirmed * Participants who have received no more than 2 lines of prior systemic therapies which must include anti-programmed cell death protein ligand-1 (anti-PD-(L)1) treatment an...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BGB-A445 is an investigational small molecule being studied for the treatment of advanced solid tumors, including urothelial carcinoma, non-small cell lung cancer, head and neck squamous cell carcinoma, nasopharyngeal carcinoma, renal cell carcinoma, and melanoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
BGB-A445 targets OX40, a receptor involved in immune response regulation. By targeting OX40, the drug is designed to modulate T-cell activity, potentially enhancing the body's immune response against tumor cells. It is being evaluated in combination with tislelizumab in clinical trials for advanced solid tumors.
BGB-A445 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 effectiveness of BGB-A445 in patients with advanced solid tumors.
BGB-A445 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and preliminary effectiveness in patients with advanced solid tumors. Two Phase 1 trials have been conducted or are ongoing.
BGB-A445 has been studied in two Phase 1 clinical trials. NCT04215978, which is completed, evaluated BGB-A445 in combination with tislelizumab in advanced solid tumors. NCT05661955, which is active but not recruiting, is investigating the combination in select advanced solid tumors including urothelial carcinoma and renal cell carcinoma.
No, BGB-A445 is not the same as tislelizumab. BGB-A445 is an investigational small molecule targeting OX40, while tislelizumab is a separate drug used in combination with BGB-A445 in clinical trials. The two drugs are being studied together to assess their combined antitumor activity in advanced solid tumors.