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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
157
Administered orally once or twice daily (QD or BID)
Administered 200 mg intravenous (IV) infusion
Administered intravenously
Icahn School of Medicine At Mount Sinai
New York, New York, United States
Phase 1a: Number of participants with dose limiting toxicities (DLTs)
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 3 Years
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to 4 Years
Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Up to 4 years
The maximum tolerated dose (MTD) of BGB-15025
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
Recommended Doses for Expansion (RDFE) of BGB-15025 monotherapy
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
RDFE of BGB-15025 in combination with tislelizumab
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
Phase 1b: Overall Response Rate (ORR) as assessed by the investigator
Time frame: Up to 2 years
Phase 1a: Overall Response Rate (ORR) as assessed by the investigator
Time frame: Up to 3 years
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Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Ut Health San Antonio Mays Cancer Center
San Antonio, Texas, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Ashford Cancer Centre Research Northeast
Windsor Gardens, South Australia, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
...and 10 more locations
Duration Of Response (DOR) as assessed by the investigator
Time frame: Up to 3 years
Disease Control Rate (DCR) as assessed by the investigator
Time frame: Up to 3 years
Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-15025
Time frame: Predose up to 8 hours postdose
Phase 1a: Minimum observed plasma concentration (Cmin) of BGB-15025
Time frame: Predose up to 8 hours postdose
Phase 1a: Time to maximum plasma concentration (Tmax) of BGB-15025
Time frame: Predose up to 8 hours postdose
Phase 1a: Half-life of (t1/2) of BGB-15025
Time frame: Predose up to 8 hours postdose
Phase 1a: Area under the concentration-time curve (AUC) of BGB-15025
Time frame: Predose up to 8 hours postdose
Phase 1a: Apparent clearance (CL/F) of BGB-15025
Time frame: Predose up to 8 hours postdose
Phase 1a: Apparent volume of distribution (Vz/F) of BGB-15025
Time frame: Predose up to 8 hours postdose
Phase 1a: Accumulation Ratio for Cmax of BGB-15025
Time frame: Predose up to 8 hours postdose
Phase 1a: Accumulation Ratio for AUC of BGB-15025
Time frame: Predose up to 8 hours postdose
Phase 1a: Metabolite to parent ratio for BGB-15025 and its metabolite
Time frame: Predose up to 8 hours postdose
Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to 3 years
Phase 1b: Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Up to 3 years
Phase 1b: Plasma Concentrations of BGB-15025
Time frame: Predose up to 8 hours postdose
Phase 1b: Plasma Concentrations of the metabolite
Time frame: Predose up to 8 hours postdose
Phase 1b: Number of participants with dose limiting toxicities (DLTs)
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 1 year