BGB-A445
Drugadministered intravenously
Other names: Gimistotug
NCT Number: NCT05661955
The objective of this study is to assess the overall response rate, evaluate the antitumor activity, and characterize the safety and tolerability of BGB-A445 alone or in combination with tislelizumab in participants With Advanced or Metastatic Urothelial Carcinoma (UC), Renal Cell Carcinoma (RCC), or Melanoma
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Beijing Cancer Hospital, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
administered intravenously
Other names: Gimistotug
administered intravenously
Other names: BGB-A317
Time frame: Up to approximately 26 months
ORR is defined as the percentage of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
Time frame: Up to approximately 26 months
DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments by the investigator using RECIST v1.1.
Time frame: Up to approximately 26 months
CBR is defined as the percentage of participants with best overall response of CR, PR, or stable disease lasting for at least 24 weeks as determined from tumor assessments by the investigator using RECIST v1.1.
Time frame: Up to 30 days after the last dose of study drugs or the initiation of new anticancer therapy, whichever comes earlier, up to 22 months
Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 [NCI-CTCAE v 5.0]), timing, seriousness, and relationship to study drug(s) as needed
BeiGene
Industry
Phase 1b/2 Study Investigating the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of the Anti-OX40 Agonist Monoclonal Antibody BGB-A445 in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Urothelial Carcinoma, Renal Cell Carcinoma, or Melanoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05078047
Adenocarcinoma, Basal Cell Carcinoma
Angers, France
View Trial DetailsNCT03228667
Adenocarcinoma, Bronchial Neoplasms
Anchorage, Alaska, United States
View Trial DetailsNCT04198766
Adenocarcinoma, Bronchial Neoplasms
Duarte, California, United States
View Trial DetailsNCT03212404
Adenocarcinoma, Adenoma
Wollongong, New South Wales, Australia
View Trial Details