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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03744468




Registration number
NCT03744468
Ethics application status
Date submitted
17/10/2018
Date registered
16/11/2018
Date last updated
6/06/2024

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
Treatment: Drugs - BGB-A425
Treatment: Drugs - Tislelizumab
Treatment: Drugs - LBL-007

Experimental: Phase 1 Dose Escalation - Dose escalation of BGB-A425 in combination with Tislelizumab in participants with advanced solid tumors

Experimental: Phase 2 Safety Lead-in - Dose escalation for Cohort A (LBL-007 + Tislelizumab) and Cohort B (BGB-A425 + LBL-007 + Tislelizumab) in participants with advanced solid tumors

Experimental: Phase 2 Dose Expansion - Further explore the safety and clinical activity of BGB-A425 and LBL-007 in combination with Tislelizumab in participants with NSCLC, HNSCC and RCC


Treatment: Drugs: BGB-A425
Humanized IgG1-variant monoclonal antibody against TIM-3

Treatment: Drugs: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1

Treatment: Drugs: LBL-007
Human anti LAG-3 IgG4-kappa antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1 Dose Escalation and Phase 2 Safety lead-in: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Approximately 2 years
Primary outcome [2] 0 0
Phase 1 Dose Escalation: Maximum Tolerated Dose (MTD)
Timepoint [2] 0 0
Approximately 2 years
Primary outcome [3] 0 0
Phase 2 Dose Expansion: Objective Response Rate (ORR)
Timepoint [3] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
Phase 1 and Phase 2 : Duration of Response (DOR)
Timepoint [1] 0 0
Phase 1 or 2 Expansion - Approximately 2-3 years each
Secondary outcome [2] 0 0
Phase 1 and Phase 2 : Disease control rate (DCR)
Timepoint [2] 0 0
Phase 1 or 2 Expansion - Approximately 2-3 years each
Secondary outcome [3] 0 0
Phase 1 and Phase 2 : Progression free survival
Timepoint [3] 0 0
Phase 2 Expansion - Approximately 3 years
Secondary outcome [4] 0 0
Pharmacokinetic (PK) Parameter: Minimum Concentration (Cmin) of BGB-425 and LBL-007
Timepoint [4] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each
Secondary outcome [5] 0 0
PK Parameter: Area Under the Curve (AUC), 0 to 21 days of BGB-425 and LBL-007
Timepoint [5] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each
Secondary outcome [6] 0 0
PK Parameter: Maximum Concentration (Cmax) of BGB-425 and LBL-007
Timepoint [6] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each
Secondary outcome [7] 0 0
PK Parameter: Clearance (CL) of BGB-425 and LBL-007
Timepoint [7] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each
Secondary outcome [8] 0 0
PK Parameter: Volume of Distribution (Vz) of BGB-425 and LBL-007
Timepoint [8] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each
Secondary outcome [9] 0 0
PK Parameter: terminal half-life (t1/2) of BGB-425 and LBL-007
Timepoint [9] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each
Secondary outcome [10] 0 0
Percentage of participants with anti-BGB-A425 and LBL-007 antibodies
Timepoint [10] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each
Secondary outcome [11] 0 0
Phase 2 Dose Expansion: Number of participants with TEAEs and SAEs including physical examinations, electrocardiograms and laboratory assessments
Timepoint [11] 0 0
Phase 1 and Phase 2- Approximately 2-3 years each

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/Phase 2
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
29/12/2027
Actual
Sample size
Target
358
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Southwest Private Hospital - Liverpool
Recruitment hospital [2] 0 0
Sunshine Coast Hospital and Health Service - Birtinya
Recruitment hospital [3] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [4] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [5] 0 0
Calvary North Adelaide Hospital - North Adelaide
Recruitment hospital [6] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 0 0
Cabrini Research and Education Institute - Malvern
Recruitment hospital [8] 0 0
Western Health Sunshine Hospital - St Albans
Recruitment hospital [9] 0 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
5006 - North Adelaide
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
3021 - St Albans
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Bordeaux
Country [2] 0 0
France
State/province [2] 0 0
Caen
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
France
State/province [4] 0 0
Villejuif
Country [5] 0 0
Italy
State/province [5] 0 0
Bologna
Country [6] 0 0
Italy
State/province [6] 0 0
Milano
Country [7] 0 0
Italy
State/province [7] 0 0
Torino
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Busan Gwang'yeogsi
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Chungcheongbukdo
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Gyeonggido
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Incheon Gwang'yeogsi
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul Teugbyeolsi
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Ulsan Gwang'yeogsi
Country [14] 0 0
Poland
State/province [14] 0 0
Bydgoszcz
Country [15] 0 0
Poland
State/province [15] 0 0
Warszawa
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Spain
State/province [18] 0 0
Sevilla

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, multicenter, nonrandomized Phase 1 and 2 clinical trial evaluating
various combinations of BGB-A425 and/or LBL-007 with tislelizumab.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03744468
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03744468