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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06427941
Registration number
NCT06427941
Ethics application status
Date submitted
20/05/2024
Date registered
24/05/2024
Date last updated
11/07/2025
Titles & IDs
Public title
A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Advanced or Metastatic Solid Tumors
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Scientific title
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Selected Advanced or Metastatic Solid Tumors
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Secondary ID [1]
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BGB-B2033-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Hepatocellular Carcinoma
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Advanced Hepatocellular Carcinoma
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Alpha-fetoprotein (AFP)-Producing Gastric Cancer
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Extragonadal Yolk Sac Tumors
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Glypican-3 (GPC3)-Positive Squamous Non-small Cell Lung Cancer
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Metastatic Solid Tumor
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Cancer
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Liver
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Cancer
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Stomach
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Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BGB-B2033
Treatment: Drugs - Tislelizumab
Experimental: Part A (Monotherapy Dose Escalation and Safety Expansion) - Ascending dose levels of BGB-B2033 monotherapy
Experimental: Part B (Combination Dose Escalation and Safety Expansion) - Cohorts of BGB-B2033 in combination with tislelizumab
Treatment: Drugs: BGB-B2033
Administered by intravenous infusion
Treatment: Drugs: Tislelizumab
Administered by intravenous infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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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;
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Timepoint [1]
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Up to approximately 2 years
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Primary outcome [2]
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Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033
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Assessment method [2]
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The MTD or MAD is defined as the highest dose that is tolerable or the highest dose administered, respectively.
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Timepoint [2]
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Up to approximately 2 years
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Primary outcome [3]
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Recommended Phase 2 dose (RP2D) of BGB-B2033 alone and in combination with tislelizumab
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Assessment method [3]
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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
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Timepoint [3]
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Up to approximately 2 years
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Secondary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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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).
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Timepoint [1]
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Up to approximately 2 years
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 2 years
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Secondary outcome [3]
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Disease Control Rate (DCR)
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Assessment method [3]
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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.
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Timepoint [3]
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Up to approximately 2 years
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Secondary outcome [4]
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Progression Free Survival (PFS)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to approximately 2 years
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Secondary outcome [5]
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Serum concentration of BGB-B2033
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Assessment method [5]
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Timepoint [5]
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Up to approximately 2 years
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Secondary outcome [6]
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Number of participants with anti-drug antibodies (ADAs) to BGB-B2033
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Assessment method [6]
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Timepoint [6]
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Up to approximately 2 years
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Eligibility
Key inclusion criteria
1. Participants with any of the following unresectable locally advanced or metastatic tumor types:
1. HCC
2. AFP-producing GC (serum AFP > 20 ng/mL or tumor tissue AFP positive by a validated IHC assay according to local testing criteria)
3. germ cell tumor including extragonadal yolk sac tumors (located in mediastinum, vagina, brain, and retroperitoneum, etc) and non-dysgerminomas
4. GPC3-positive squamous NSCLC
2. = 1 evaluable lesion for dose escalation and = 1 measurable lesion for safety expansion, per RECIST v1.1
3. ECOG Performance Status score = 1
4. Adequate organ functions
5. Tumor tissues will be required for certain parts of the study
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Prior therapy targeting glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (also known as CD137)
2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
3. Active autoimmune diseases or history of autoimmune diseases that may relapse
4. Any malignancy = 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
5. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication = 14 days before the first dose of study drug(s).
6. Certain comorbidities in the lung, heart, bleeding condition and infections.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/07/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/10/2026
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Actual
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Sample size
Target
140
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Country [2]
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United States of America
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State/province [2]
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Tennessee
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Country [3]
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United States of America
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State/province [3]
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Washington
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Country [4]
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China
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State/province [4]
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Anhui
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Country [5]
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China
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State/province [5]
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Fujian
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Country [6]
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China
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State/province [6]
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Guangdong
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Country [7]
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China
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State/province [7]
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Heilongjiang
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Country [8]
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China
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State/province [8]
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Hubei
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Country [9]
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China
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State/province [9]
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Hunan
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Country [10]
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China
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State/province [10]
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Jiangxi
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Country [11]
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China
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State/province [11]
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Zhejiang
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Country [12]
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Korea, Republic of
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State/province [12]
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Gyeonggi-do
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Country [13]
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Korea, Republic of
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State/province [13]
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Seoul Teugbyeolsi
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Country [14]
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New Zealand
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State/province [14]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BeiGene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is a first-in-human (FIH) Phase 1 study of BGB-B2033 to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of the BGB-B2033 in participants with 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). The study will also identify the recommended Phase 2 dose (RP2D) of BGB-B2033 alone and in combination with tislelizumab for subsequent studies. BGB-B2033 will be administered by intravenous infusion. The Phase 1 study will be conducted in 2 parts: Part A (Monotherapy Dose Escalation and Safety Expansion) and Part B (Combination Dose Escalation and Safety Expansion).
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Trial website
https://clinicaltrials.gov/study/NCT06427941
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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BeiGene
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Director
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Address
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Country
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Phone
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1.877.828.5568
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06427941
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