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ACTIVE NOT RECRUITING Phase 1

A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

NCT06422520 · View on ClinicalTrials.gov ↗

Study Summary

This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors. Study details include: * The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion). * The visit frequency will be approximately every 21 days during study treatment. Maximum treatment duration will be up to two years. * The study duration is estimated to be approximately 5 years.

Conditions Studied

Interventions

  • DRUG Tislelizumab
  • DRUG BGB-C354

Study Locations (14)

Texas

  • The University of Texas Md Anderson Cancer Center — Houston
  • Next Oncology — San Antonio

Victoria

  • St Vincents Hospital Melbourne — Fitzroy
  • The Alfred Hospital — Melbourne

Florida

  • Florida Cancer Specialist Research Institute Lake Nona — Orlando

Massachusetts

  • Dana Farber Cancer Institute — Boston

Missouri

  • Washington University School of Medicine — St Louis

New South Wales

  • Westmead Hospital — Westmead

Western Australia

  • One Clinical Research — Nedlands

Beijing Municipality

  • Beijing Cancer Hospital — Beijing

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2024-07-08
Est. Completion 2027-01-31
Phase Phase 1

Sponsor

BeiGene

91 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06422520

The ClinicalTrials.gov registry entry for NCT06422520 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BeiGene, which has 91 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions — of which Tislelizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06422520 reports 14 study locations spanning 12 distinct geographic areas — top geographies include Texas, Victoria, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06422520 about?

NCT06422520 is a clinical study titled "A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors". This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors. Study details include: * The study will be conducted in 2 phases...

What is the current status of trial NCT06422520?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2024-07-08. Estimated completion is 2027-01-31.

What conditions does trial NCT06422520 study?

This clinical trial studies the following conditions: Advanced Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06422520?

The interventions under investigation include: Tislelizumab (DRUG), BGB-C354 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06422520?

This trial is sponsored by BeiGene, which has 91 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06422520 being conducted?

This trial has 14 study locations across Florida, Massachusetts, Missouri, Texas, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial