Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BGB-A445
Gimistotug · 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...
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Gimistotug is an investigational small molecule being developed by BeOne Medicines Ltd. for the treatment of non-small cell lung cancer. It is in Phase 2 clinical development and has been studied in a controlled trial in combination with other investigational agents in participants with non-small cell lung cancer.
Gimistotug is being evaluated for the treatment of non-small cell lung cancer. It was studied in a Phase 2 trial in combination with other investigational agents in participants with this condition. It is investigational and has not been established as a treatment option outside of clinical research.
Gimistotug is being developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company is the sponsor of the Phase 2 clinical program evaluating the small molecule in non-small cell lung cancer.
Gimistotug is in Phase 2 clinical development. It is an investigational small molecule and is not approved for commercial use. The Phase 2 trial evaluating it in non-small cell lung cancer has been completed, and no active trials are currently listed.
Gimistotug has been studied in one clinical trial, NCT06029127, titled A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer. This completed Phase 2 trial enrolled 35 participants across China and South Korea.
Yes, Gimistotug is also known as BGB-A445. The Phase 2 trial NCT06029127 refers to the drug by both names, evaluating Gimistotug (BGB-A445) in combination with other investigational agents in participants with non-small cell lung cancer.