Trial Title:
A Study of BGB-30813 Alone or in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors
NCT ID:
NCT05904496
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Tislelizumab
Conditions: Keywords:
DGKζ Inhibitor
BGB-30813
Anti-PD-1 Monoclonal Antibody
Tislelizumab
Advanced or Metastatic Solid Tumors
Diacylglycerol kinase
BGB-A317
NSCLC
Immunotherapy
HNSCC
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BGB-30813
Description:
Specified dose administered on specified days
Arm group label:
Phase 1a: Dose Escalation Part A: BGB-30813 Monotherapy
Arm group label:
Phase 1a: Dose Escalation Part B: BGB-30813 + Tislelizumab
Arm group label:
Phase 1b: Dose Expansion BGB-30813 in Combination with Tislelizumab
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Specified dose administered on specified days
Arm group label:
Phase 1a: Dose Escalation Part B: BGB-30813 + Tislelizumab
Arm group label:
Phase 1b: Dose Expansion BGB-30813 in Combination with Tislelizumab
Other name:
BGB-A317
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 or 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.
Detailed description:
This study will test whether taking BGB-30813 alone or with tislelizumab can help treat
patients with cancer that has spread throughout the body or is locally advanced. The two
main goals of the study are to ensure that the treatments are safe by monitoring side
effects and to determine the number of participants who respond well to treatment either
partially or completely. The combination of BGB-30813 with other drugs that target immune
checkpoints may work together to stop or prevent cancer activity.
Approximately 191 participants will participate. In the first part of the study,
participants will be given different doses of BGB-30813 either alone or with tislelizumab
to find the dose that is best tolerated. BGB-30813 will be given orally and tislelizumab
will be given through a vein. In the second part of the study, the selected dose of
BGB-30813, either alone or with tislelizumab, will be given to a larger number of
participants from different parts of the world to see if the treatments can improve the
signs and symptoms of their cancer. Treatments will continue until participants are no
longer considered to be receiving benefits, have unacceptable side effects, or withdraw
consent.
Criteria for eligibility:
Criteria:
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
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
- ≥ Grade 3 immune-mediated adverse events on prior immuno-oncology agent (anti-PD-1
or anti-CTLA4 antibodies or other experimental drugs)
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Md Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Next Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Facility:
Name:
Peter Maccallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Facility:
Name:
Linear Clinical Research
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Facility:
Name:
Hospital Universitario Vall Dhebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
Start Madrid Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Start date:
July 19, 2023
Completion date:
May 2026
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05904496
