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RecruitingLast updated: 2 May 2024

BGB-A317-30813-101: This study will test whether taking a new anti-cancer drug (called BGB-30813) alone, or in addition to targeted therapy (called tislelizumab) can help treat people with cancer that has spread throughout the body or is locally advancedA 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

Clinical summary

Summary

This is study has two stages. Stage 1 (dose escalation) has got two experimental arms. In Stage 1 Arm A, participants will receive escalating doses of BGB-30813 alone. In Stage 1 Arm B, participants will receive escalating doses of BGB-30813, and they will also receive tislelizumab. This first stage is trying to find the dose that is best tolerated. BGB-30813 will be given orally and tislelizumab will be given through a vein. The second stage (Dose Expansion) will further test the dose of BGB-30813 selected in the first stage, either alone or with tislelizumab. This stage is testing whether the treatments can improve the signs and symptoms of their cancer.

Conditions

This trial is treating patients with locally advanced, inoperable or metastatic solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

BGB-A317-30813-101

More information

Trial Identifiers

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Trial sponsor

BeiGene

Scientific Title

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

Eligibility

Inclusion

  • 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 ζ (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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Recruiting hospitals

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