Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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

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
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
Secondary ID [1] 0 0
BGB-B2033-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Hepatocellular Carcinoma 0 0
Advanced Hepatocellular Carcinoma 0 0
Alpha-fetoprotein (AFP)-producing Gastric Cancer 0 0
Extragonadal Yolk Sac Tumors 0 0
Glypican-3 (GPC3)-positive Squamous Non-small Cell Lung Cancer 0 0
Metastatic Solid Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Liver
Cancer 0 0 0 0
Stomach
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to approximately 2 years
Primary outcome [2] 0 0
Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033
Timepoint [2] 0 0
Up to approximately 2 years
Primary outcome [3] 0 0
Recommended Phase 2 dose (RP2D) of BGB-B2033 alone and in combination with tislelizumab
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Progression Free Survival (PFS)
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
Serum concentration of BGB-B2033
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Number of participants with anti-drug antibodies (ADAs) to BGB-B2033
Timepoint [6] 0 0
Up to approximately 2 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
China
State/province [3] 0 0
Anhui
Country [4] 0 0
China
State/province [4] 0 0
Fujian
Country [5] 0 0
China
State/province [5] 0 0
Guangdong
Country [6] 0 0
China
State/province [6] 0 0
Heilongjiang
Country [7] 0 0
China
State/province [7] 0 0
Hubei
Country [8] 0 0
China
State/province [8] 0 0
Hunan
Country [9] 0 0
China
State/province [9] 0 0
Jiangxi
Country [10] 0 0
China
State/province [10] 0 0
Zhejiang
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Gyeonggi-do
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul Teugbyeolsi
Country [13] 0 0
New Zealand
State/province [13] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
1.877.828.5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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