Study Stopped
The Sponsor has made the decision to discontinue the clinical development of BGB-30813 and close the study based on imbalanced benefit/risk profile in the BGB-A317-30813-101 study.
A Study of BGB-30813 Alone or in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the DGKζ Inhibitor BGB-30813, Alone or in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Solid Tumors
4 other identifiers
interventional
44
4 countries
11
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2023
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedStudy Start
First participant enrolled
July 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2025
CompletedSeptember 16, 2025
September 1, 2025
2.1 years
June 6, 2023
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Phase 1a: Dose Escalation: Number of Participants Experiencing Adverse Events (AEs), Serious Adverse Events (SAEs) and Dose-Limiting Toxicities (DLTs)
Number of participants experiencing AEs and SAEs, including physical examination findings, electrocardiograms (ECGs), and lab assessments as needed; and AEs meeting protocol-defined DLT criteria.
From the first dose of study drug(s) to 30 days after the last dose; approximately 6 months
Phase 1a: Dose Escalation: The Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD)
The MTD or MAD is defined as the highest dose at which 30% of participants experience a DLT or the highest dose administered, respectively.
Up to approximately 6 months
Phase 1a and 1b: Recommended dose(s) for Expansion (RDFE[s]) of BGB-30813 Alone or in Combination with Tislelizumab
The RDFE(s) of BGB-30813 alone or in combination with tislelizumab, determined based upon the MTD or MAD and other relevant data.
Up to approximately 6 months
Phase 1b: Dose Expansion: Overall Response Rate (ORR) as Determined by the Investigator
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined from tumor assessments by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Up to approximately 12 months
Secondary Outcomes (11)
Phase 1a: Dose Escalation: ORR as Determined by the Investigator
Up to approximately 12 months
Phase 1a: Dose Escalation: Maximum Observed Plasma Concentration (Cmax) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Up to approximately 6 months
Phase 1a: Dose Escalation: Observed Plasma Trough Concentration (Ctrough) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Up to approximately 6 months
Phase 1a: Dose Escalation: Area under the concentration-time curve (AUC) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Up to approximately 6 months
Phase 1a: Dose Escalation: Half-life (t1/2) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Up to approximately 6 months
- +6 more secondary outcomes
Study Arms (3)
Phase 1a: Dose Escalation Part A: BGB-30813 Monotherapy
EXPERIMENTALPhase 1a: Dose Escalation Part B: BGB-30813 + Tislelizumab
EXPERIMENTALPhase 1b: Dose Expansion BGB-30813 in Combination with Tislelizumab
EXPERIMENTALInterventions
Specified dose administered on specified days
Specified dose administered on specified days
Eligibility Criteria
You may qualify if:
- 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 non-small cell lung cancer (NSCLC), head neck squamous cell cancer (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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (11)
Hackensack University Medical Center
Hackensack, New Jersey, 07601-1915, United States
Md Anderson Cancer Center
Houston, Texas, 77030-3907, United States
Next Oncology
San Antonio, Texas, 78229-6028, United States
Monash Health
Clayton, Victoria, 3168, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Linear Clinical Research
Nedlands, Western Australia, 6009, Australia
Jinan Central Hospital
Jinan, Shandong, 250013, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Hospital Universitario Vall Dhebron
Barcelona, 08035, Spain
Start Madrid Fundacion Jimenez Diaz
Madrid, 28040, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2023
First Posted
June 15, 2023
Study Start
July 19, 2023
Primary Completion
August 20, 2025
Study Completion
August 20, 2025
Last Updated
September 16, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.