A Study of BGB-30813 Alone or in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors

Last updated: September 10, 2025
Sponsor: BeiGene
Overall Status: Terminated

Phase

1

Condition

Head And Neck Cancer

Neoplasms

Treatment

BGB-30813

Tislelizumab

Clinical Study ID

NCT05904496
BGB-A317-30813-101
CTR20233404
2023-503996-38
U1111-1290-6118
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Phase 1a (Dose Escalation):

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

  • Eligible tumor types are immune sensitive solid tumors such as non-small celllung cancer (NSCLC), head neck squamous cell cancer (HNSCC), small cell lungcancer, hepatocellular carcinoma, esophageal cancer, gastric orgastroesophageal carcinoma, nasopharyngeal carcinoma, triple-negative breastcancer, urothelial carcinoma, renal cell carcinoma, cervical cancer,endometrial carcinoma, cutaneous squamous cell carcinoma, melanoma, Merkel cellcarcinoma, mesothelioma, microsatellite instability (MSI)-high, tumor mutationburden (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 emergingdata

  • ≥ 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 methodof birth control for the duration of the study

  • Adequate organ function as indicated by the following laboratory values up to firstdose of study treatment: Hemoglobin≥ 90 grams per liter (g/L), Absolute neutrophilcount ≥ 1.5 x 109/L , Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (< 3x ULN for participants with Gilbert syndrome ), aspartate aminotransferase (AST) andalanine aminotransferase (ALT) ≤ 2.5 x ULN

Exclusion

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 forthe specific cancer under investigation in this study and any locally recurringcancer 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-1or anti-CTLA4 antibodies or other experimental drugs)

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: BGB-30813
Phase: 1
Study Start date:
July 19, 2023
Estimated Completion Date:
August 20, 2025

Study 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 200 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.

Connect with a study center

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Monash Health

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Site Not Available

  • Peter Maccallum Cancer Centre

    Melbourne 2158177, Victoria 2145234 3000
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan 1805753, Shandong 1796328 250013
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan 1805753, Shandong 1796328 250117
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan 1805753, Shandong 1796328 250021
    China

    Site Not Available

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Vall Dhebron

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Start Madrid Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Start Madrid Fundacion Jimenez Diaz

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601-1915
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack 5098706, New Jersey 5101760 07601-1915
    United States

    Site Not Available

  • Md Anderson Cancer Center

    Houston, Texas 77030-3907
    United States

    Site Not Available

  • Next Oncology

    San Antonio, Texas 78229-6028
    United States

    Site Not Available

  • Md Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030-3907
    United States

    Site Not Available

  • Next Oncology

    San Antonio 4726206, Texas 4736286 78229-6028
    United States

    Site Not Available

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