Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-A445 · 2 trials · 8 indications
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 |
|---|---|---|
| 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 |
|---|---|---|
| BGB-A445 | DRUG | administered intravenously |
| Tislelizumab | DRUG | administered intravenously |
Key Inclusion Criteria: 1. Participants who were histologically or cytologically confirmed advanced and/or metastatic cancer. UC participants (Cohort A and B), RCC patients (Cohort C and D) or melanoma participants (Cohort E and F) who have received at least 1 but no more than 3 lines of prior syst...
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 regulation. By targeting OX40, the drug is designed to modulate immune responses in the tumor microenvironment. 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 efficacy 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 the FDA or other regulatory agencies. The ongoing and completed trials are early-stage studies focused on safety, tolerability, and preliminary antitumor activity.
BGB-A445 has been studied in two Phase 1 trials. NCT04215978, completed, enrolled 204 participants with advanced solid tumors across multiple countries. NCT05661955, active but not recruiting, is enrolling 113 participants in China with urothelial carcinoma, renal cell carcinoma, and melanoma. Both trials combine BGB-A445 with tislelizumab.
No, BGB-A445 is not the same as tislelizumab. BGB-A445 is an OX40-targeting small molecule, while tislelizumab is a PD-1 inhibitor. In clinical trials, BGB-A445 is being studied in combination with tislelizumab to evaluate their combined antitumor activity in advanced solid tumors.