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NCT06422520 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Solid Tumor, sponsored by BeiGene.

Active
Registry status
Phase 1
Development phase
120
Enrollment target
14
Study locations

NCT06422520: Active Phase 1 study of Advanced Solid Tumor, sponsored by BeiGene.

NCT06422520 is a Phase 1 study of Advanced Solid Tumor that is active but no longer recruiting, run by BeiGene. The registered enrollment target is 120 participants, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (37% lower). The trial reports 14 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06422520, a Phase 1 study of Advanced Solid Tumor, is active but no longer recruiting, sponsored by BeiGene.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
120 participants
Enrollment target
14
Study locations

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.

Primary Outcome

Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria

Conditions Studied

Advanced Solid Tumor

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
BeiGene

65 total trials

What the registry record for NCT06422520 still lists

NCT06422520 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (37% lower).

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.

NCT06422520 lists 14 locations in 12 states (Texas, Victoria, Florida).

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.

What interventions are being tested in trial NCT06422520?

The interventions under investigation include: Tislelizumab (DRUG), BGB-C354 (DRUG).

Who is sponsoring clinical trial NCT06422520?

This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06422520's enrollment target sits among peer trials

120 104th of 189 higher than 85 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT06422520, the US trial registry maintained by the National Library of Medicine. NCT06422520 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.