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RecruitingLast updated: 3 November 2023

This phase I study is evaluating how safe, tolerable and effective a new cancer drug (BGB-24714) is alone, and in combination with chemotherapy (paclitaxel) in people with advanced or metastatic solid cancersA Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of Second Mitochondrial-derived Activator of Caspases Mimetic BGB-24714 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced or Metastatic Solid Tumors

Clinical summary

Summary

This is a dose escalation and dose expansion study.

The Dose Escalation phase has two parts. In Part A, participants will receive increasing doses of BGB-24714 alone, administered orally. In Part B, participants will receive increasing doses of BGB-24714 (orally) in combination with paclitaxel (administered intravenously {via IV]).

In the Dose Expansion phase, eligible participants will receive the recommended phase 2 dose (as determined in the Dose Escalation phase) of BGB-24714 alone, or in combination with chemotherapy.

Conditions

This trial is treating patients with advanced or metastatic solid cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of Second Mitochondrial-derived Activator of Caspases Mimetic BGB-24714 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced or Metastatic Solid Tumors

Eligibility

Inclusion

  1. Participants must sign a written informed consent form (ICF); and agree to comply with study requirement

  2. Phase 1a (Dose Escalation):

    Part A, A-CN, and B: Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumor previously treated with standard systemic therapy or for whom treatment is not available or not tolerated Note: Only participants in mainland China will be eligible for Part A-CN. Part C: Participant has histologically or cytologically confirmed, locally advanced, unresectable Stage III Non-small cell lung cancer (NSCLC) suitable for definitive chemoradiotherapy (CRT) Part D: Participant with locally advanced, histologically confirmed esophageal squamous cell carcinoma (ESCC) suitable for definitive CRT

  3. Participants must be able to provide an archived formalin-fixed paraffin embedded (FFPE) tumor tissue sample. If archival tissue is not available, fresh tumor biopsy is mandatory for Part A, A-CN and B.
  4. Part A, A-CN, B: ≥ 1 measurable lesion per Response evaluation criteria in solid tumors (RECIST) v1.1
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

Exclusion

  1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  2. 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
  3. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s).
  4. Clinically significant infection requiring systemic therapy ≤ 14 days before the first dose of study drug(s).
  5. Prior exposure to agents with second mitochondria-derived activator of caspases (SMAC) mimetics, or other Inhibitors of apoptosis proteins (IAPs) antagonists.

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.
  • 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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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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