BGB-15025
DrugAdministered orally once or twice daily (QD or BID)
NCT Number: NCT04649385
The primary objective of this study is to assess the safety and tolerability of BGB-15025 alone and in combination with tislelizumab; and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended Phase 2 doses (RP2D) of BGB-15025 alone and in combination with tislelizumab in participants with advanced solid tumors.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Prince of Wales Hospital, Randwick, New South Wales, Australia
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 orally once or twice daily (QD or BID)
Administered 200 mg intravenous (IV) infusion
Other names: BGB-A317
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Time frame: Up to 3 Years
Participants will be considered evaluable for DLTs if they 1) received ≥ 80% of each scheduled study treatment administration during the DLT assessment window and/or 2) experienced a DLT.
Time frame: Up to 4 Years
Time frame: Up to 4 years
Time frame: Up to 3 Years
The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
Time frame: Up to 3 years
The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
Time frame: Up to 3 years
The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
Time frame: Up to 2 years
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Predose up to 8 hours postdose
Time frame: Predose up to 8 hours postdose
Time frame: Predose up to 8 hours postdose
Time frame: Predose up to 8 hours postdose
Time frame: Predose up to 8 hours postdose
Time frame: Predose up to 8 hours postdose
Time frame: Predose up to 8 hours postdose
Time frame: Predose up to 8 hours postdose
Time frame: Predose up to 8 hours postdose
Time frame: Predose up to 8 hours postdose
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Predose up to 8 hours postdose
Time frame: Predose up to 8 hours postdose
Time frame: Up to 1 year
Participants will be considered evaluable for DLTs if they 1) received ≥ 80% of each scheduled study treatment administration during the DLT assessment window and/or 2) experienced a DLT.
BeiGene
Industry
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
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.
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