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Closed (no longer recruiting)Last updated: 7 February 2024

This phase I study is evaluating how safe, tolerable and effective a new cancer drug (BGB-B167) is alone, and in combination with targeted therapy (tislelizumab) in people with advanced solid cancersA Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B167, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors

Clinical summary

Summary

This is a dose escalation and dose expansion study. In this dose escalation phase, eligible participants will receive increasing dose levels of BGB-B167 (administered intravenously [IV]), either alone, or in combination with tislelizumab (aministered via IV). In the dose expansion phase, eligible participants will either receive BGB-B167 alone (via IV), or in combination with tislelizumab (via IV).

Conditions

This trial is treating patients with advanced solid cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

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 BGB-B167, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors

Eligibility

Inclusion

  • Age 18 or older
  • Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors previously treated with standard systemic therapy or for whom treatment is not available, not tolerated, or refused, or not expected to provide significant clinical benefit or be tolerated in the medical judgement of the investigator
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  • Adequate organ function as indicated by laboratory values during screening or ≤ 7 days before the first dose of study drug(s)

Exclusion

  • Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  • Active autoimmune diseases or history of autoimmune diseases that may relapse
  • Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
  • History of severe hypersensitivity reactions to other monoclonal antibody products or their excipients
  • Women who are pregnant or are breastfeeding

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • 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.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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

Participating hospitals

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Closed hospitals

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