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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/NCT05904496




Registration number
NCT05904496
Ethics application status
Date submitted
6/06/2023
Date registered
15/06/2023
Date last updated
20/05/2024

Titles & IDs
Public title
A Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-30813
Scientific title
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the DGK? Inhibitor BGB-30813, Alone or in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
U1111-1290-6118
Secondary ID [2] 0 0
BGB-A317-30813-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-30813
Treatment: Drugs - Tislelizumab

Experimental: Phase 1a: Dose Escalation Part A: BGB-30813 Monotherapy -

Experimental: Phase 1a: Dose Escalation Part B: BGB-30813 + Tislelizumab -

Experimental: Phase 1b: Dose Expansion BGB-30813 in Combination with Tislelizumab -


Treatment: Drugs: BGB-30813
Specified dose administered on specified days

Treatment: Drugs: Tislelizumab
Specified dose administered on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1a: Dose Escalation: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Dose-Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Up to Approximately 23 months
Primary outcome [2] 0 0
Phase 1a : Dose Escalation: The Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD) and Recommended dose(s) for Expansion (RDFE[s]) of BGB-30813 Alone or in Combination with Tislelizumab
Timepoint [2] 0 0
Up to approximately 23 months
Primary outcome [3] 0 0
Phase 1b: Dose Expansion: Overall Response Rate (ORR) as Determined by the Investigator
Timepoint [3] 0 0
Up to approximately 2 years and 11 months
Secondary outcome [1] 0 0
Phase 1a: Dose Escalation: ORR as Determined by the Investigator
Timepoint [1] 0 0
Up to approximately 23 months
Secondary outcome [2] 0 0
Phase 1a: Maximum Observed Plasma Concentration (Cmax) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Timepoint [2] 0 0
From Cycle 1 Day 1 up to Cycle 9 Day 1
Secondary outcome [3] 0 0
Phase 1a: Dose Escalation: Observed Plasma Trough Concentration (Ctrough) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Timepoint [3] 0 0
From Cycle 1 Day 1 up to Cycle 9 Day 1
Secondary outcome [4] 0 0
Phase 1a: Dose Escalation: Area Under the concentration-time curve (AUC) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Timepoint [4] 0 0
From Cycle 1 Day 1 up to Cycle 9 Day 1
Secondary outcome [5] 0 0
Phase 1a: Dose Escalation: Half-life (t1/2) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Timepoint [5] 0 0
From Cycle 1 Day 1 up to Cycle 9 Day 1
Secondary outcome [6] 0 0
Phase 1b: Dose Expansion: Number of Participants Experiencing TEAEs, and SAEs
Timepoint [6] 0 0
Up to approximately 2 years and 11 months
Secondary outcome [7] 0 0
Phase 1b: Dose Expansion: Duration of Response (DOR)
Timepoint [7] 0 0
Up to approximately 2 years and 11 months
Secondary outcome [8] 0 0
Phase 1b: Dose Expansion: Disease Control Rate (DCR)
Timepoint [8] 0 0
Up to approximately 2 years and 11 months
Secondary outcome [9] 0 0
Phase 1b: Dose Expansion: Progression Free Survival (PFS)
Timepoint [9] 0 0
Up to approximately 2 years and 11 months
Secondary outcome [10] 0 0
Phase 1b: Dose Expansion: Clinical Benefit Rate (CBR)
Timepoint [10] 0 0
Up to approximately 2 years and 11 months

Eligibility
Key inclusion criteria
- Phase 1a (Dose Escalation):

- Participants with histologically or cytologically confirmed advanced, metastatic,
and unresectable solid tumors who have previously received available standard
systemic therapy or for whom treatment is not available or not tolerated and who
have not received any prior therapy targeting diacylglycerol kinase ? (DGK)

- Eligible tumor types are immune sensitive solid tumors such as NSCLC, HNSCC,
small cell lung cancer, hepatocellular carcinoma, esophageal cancer, gastric
or gastroesophageal carcinoma, nasopharyngeal carcinoma, triple-negative
breast cancer, urothelial carcinoma, renal cell carcinoma, cervical cancer,
endometrial carcinoma, cutaneous squamous cell carcinoma, melanoma, Merkel
cell carcinoma, mesothelioma, microsatellite instability (MSI)-high, tumor
mutation burden (TMB)-high, or mismatch repair deficient solid tumors

- Prior checkpoint inhibitor (CPI) therapy is allowed

- Phase 1b (Dose Expansion):

- Participants with selected advanced or metastatic solid tumors including NSCLC,
HNSCC, and additional potential tumor types to be defined based on emerging data

- = 1 measurable lesion per RECIST v1.1

- Eastern Cooperative Group Oncology Performance (ECOG) Performance Status score = 1

- Females of childbearing potential must be willing to use a highly effective method of
birth control for the duration of the study

- Adequate organ function as indicated by the following laboratory values up to first
dose of study treatment: Hemoglobin= 90 grams per liter (g/L), Absolute neutrophil
count = 1.5 x 109/L , Serum total bilirubin = 1.5 x upper limit of normal (ULN) (< 3 x
ULN for participants with Gilbert syndrome ), aspartate aminotransferase (AST) and
alanine aminotransferase (ALT) = 2.5 x ULN
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous therapy targeting DGK

- Active leptomeningeal disease or uncontrolled symptomatic central nervous system (CNS)
metastasis

- Active autoimmune diseases or history of autoimmune diseases that may relapse

- Any active malignancy = 2 years before the first dose of study treatment except for
the specific cancer under investigation in this study and any locally recurring cancer
that has been treated with curative intent

- Systemic anticancer therapy, including chemotherapy = 21 days or 5 half-lives
(whichever is shorter) before the first dose of study drugs

Note: Other 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
19/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
209
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment hospital [2] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Spain
State/province [3] 0 0
Barcelona
Country [4] 0 0
Spain
State/province [4] 0 0
Madrid

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a First in Human (FIH) Phase 1, multicenter, open label, dose escalation and dose
expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and
preliminary antitumor activity of BGB-30813 as monotherapy and in combination with
tislelizumab in participants with advanced or metastatic solid tumors. The study will be
conducted in 2 parts: Phase 1a dose escalation and Phase 1b dose expansion.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05904496
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05904496