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Safety and Preliminary Effectiveness of BGB-A445 in Combination With Tislelizumab in Participants With Advanced Solid Tumors

NCT04215978 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-10-03

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of BGB-A445 alone and in combination with tislelizumab in participants with advanced solid tumors; and to determine the maximum tolerated dose(s) (MTD) or maximum administered dose(s) (MAD) and recommended Phase 2 doses (RP2D) of BGB-A445 alone and in combination with tislelizumab.

Conditions

  • Advanced Solid Tumor
  • Non Small Cell Lung Cancer
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Nasopharyngeal Carcinoma (NPC)

Interventions

DRUG

BGB-A445

Administered as specified in the treatment arm

DRUG

tislelizumab

Administered as specified in the treatment arm

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2025-01-24
Completion
2025-01-24
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Malaysia
  • New Zealand
  • South Korea
  • Taiwan
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04215978 on ClinicalTrials.gov