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RecruitingLast updated:1 September 2023

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.

Age

People18+

Phase

I

Trial Acronym

BGB-A317-30813-101

More information

Trial Identifiers

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Commercial 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

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

Exclusion

  • You are able to swallow medication by mouth.
  • 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.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.
Message

Clinical trials have complex eligibility criteria.

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

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