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RecruitingLast updated:15 August 2023

OX40: This phase I trial is evaluating a new targeted therapy alone and in combination with another type of targeted therapy to see if it is safe and tolerable for advanced cancer patientsPhase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of the Anti OX40 Agonist Monoclonal Antibody BGB-A445 in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

Clinical summary

Summary

This is a dose escalation and expansion study. In the dose escalation phase (Phase Ia), eligible patients will receive intravenous BGB-A445 as a monotherapy in sequential cohorts of approximately 5 increasing dose levels on day 1 of each 21 day treatment cycle, OR receive BGB-A445 in combination with tislelizumab in sequential cohorts of approximately 3 increasing dose levels on day 1 of each 21 day treatment cycle. In the dose expansion phase (Phase Ib), eligible patients will receive a recommended Phase 2 does of intravenous BGB-A445 alone or in combination with tislelizumab as determined by the dose escalation phase.

Age

People18+

Phase

I

Trial Acronym

OX40

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Trial Identifiers

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Commercial Sponsor

BeiGene Australia Pty Ltd

Scientific Title

Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of the Anti OX40 Agonist Monoclonal Antibody BGB-A445 in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced 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 have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.
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Clinical trials have complex eligibility criteria.

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