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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03744468




Registration number
NCT03744468
Ethics application status
Date submitted
17/10/2018
Date registered
16/11/2018
Date last updated
23/09/2024

Titles & IDs
Public title
Study of BGB-A425 and LBL-007 in Combination with Tislelizumab in Advanced Solid Tumors
Scientific title
Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Various Combinations of BGB-A425 and LBL-007 with Tislelizumab in Patients with Advanced Solid Tumors
Secondary ID [1] 0 0
U1111-1278-0027
Secondary ID [2] 0 0
BGB-900-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic Solid Tumors for Phase 1,Dose Escalation and Phase 2 Safety Lead-in, HNSCC, NSCLC and RCC Participants for Phase 2 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Phase 1 Dose Escalation - Dose escalation of BGB-A425 in combination with Tislelizumab in participants with advanced solid tumors
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Key

Has Eastern Cooperative Oncology Group (ECOG) Performance Status =1.

* Adequate organ function
* Phase 1 Dose Escalation + Phase 2 Safety Lead-In: Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have previously received standard systemic therapy or for which treatment is not available, not tolerated or refused.
* Phase 2 Dose-Expansion: Participants with one of the following histologically or cytologically confirmed solid tumors:
* For HNSCC participants in cohort 1,4 and 6 (PD-L1 positive):

Recurrent/metastatic head and neck squamous cell cancer of the oral cavity, oropharynx, hypopharynx, and/or larynx whose tumor is not amenable to local therapy with curative intent (ie, surgery or radiation therapy with or without chemotherapy • For NSCLC participants in Cohort 2, 5 and 7 (PD-L1 positive): Locally recurrent Stage IIIB, stage IIIC or Stage IV squamous or non-squamous non-small cell lung cancer

• For RCC participants in Cohort 3: Locally advanced unresectable or metastatic and histologically confirmed renal cell carcinoma with a clear cell histology

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* NSCLC patients with known EGFR mutation, BRAF mutation, ALK fusion, or ROS1 fusion
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
* Active autoimmune diseases or history of autoimmune diseases that may relapse.
* Interstitial lung disease, noninfectious pneumonitis or uncontrolled lung diseases
* Uncontrolled diabetes or significant cardiac issues
* Infections requiring systemic antibacterial, antifungal, or antiviral therapy
* History of severe hypersensitivity reactions to other monoclonal antibodies
* History of HIV infection or untreated chronic hepatitis B or chronic hepatitis B virus carriers
* Major surgical procedure within 28 days before study drug administration
* Chemotherapy, radiotherapy, immunotherapy or any investigational therapies within 28 days (PH 2 Safety Lead-In) or 14 days (PH 2 Dose Expansion) or 5 half-lives of (whichever is shorter) of first administration of study drug(s).
* With infections (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy = 14 days prior to the first dose of study drug(s), or a requirement for chronic prophylactic treatment with antibiotics.
* Concurrent participation in another therapeutic clinical trial
* Received prior therapies targeting TIM-3and/or LAG3

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Parallel
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
13/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
358
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

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
Hua-Xin Gao
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
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

No information has been provided regarding IPD availability


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/NCT03744468