This is a first-in-human (FIH) clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of BGB-B2033 administered as monotherapy and in combination with tislelizumab, with or without bevacizumab. The study will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors/non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Administered by intravenous infusion
Administered by intravenous infusion
Administered by intravenous infusion
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
RECRUITINGUpmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, United States
RECRUITINGScri Oncology Partners
Nashville, Tennessee, United States
RECRUITINGAnhui Provincial Hospital
Hefei, Anhui, China
RECRUITINGMengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGNanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGUnion Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGThe Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITING...and 6 more locations
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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/American Society for Transplantation and Cellular Therapy \[ASTCT\] for cytokine release syndrome \[CRS\] and immune effector cell-associated neurotoxicity syndrome \[ICANS\]), timing, seriousness, and relationship to study therapy; assessment of adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria;
Time frame: Up to approximately 2 years
Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033
The MTD or MAD is defined as the highest dose that is tolerable or the highest dose administered, respectively.
Time frame: Up to approximately 2 years
Recommended Phase 2 dose (RP2D) of BGB-B2033
The RP2D(s) will be determined based on a biologically effective dose by taking the totality of available preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration
Time frame: Up to approximately 2 years
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Time frame: Up to approximately 2 years
Duration of Response (DOR)
DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first.
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments using RECIST v1.1.
Time frame: Up to approximately 2 years
Progression Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease using RECIST v1.1 or death, whichever occurs first.
Time frame: Up to approximately 2 years
Serum concentration of of BGB-B2033
Time frame: Up to approximately 2 years
Number of participants with anti-drug antibodies (ADAs) to BGB-B2033
Time frame: Up to approximately 2 years
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