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A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants With Select Advanced Solid Tumors.

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorBeiGene
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites revised (18)v17 See this version in full on ClinicalTrials.gov ↗
  2. Study sites revised (18)v16 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv15
  4. Enrollment target: estimated 202 to confirmed 113 Primary completion date changed from estimate of Oct 2026 to May 27, 2025 · Start date: Jan 19, 2023 to Jan 9, 2023 · Secondary endpoints: 4 to 3v14 Show 3 more changesShow less
    • Primary completion date changed from estimate of Oct 2026 to May 27, 2025
    • Start date: Jan 19, 2023 to Jan 9, 2023
    • Secondary endpoints: 4 to 3

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 19 to 18v13
Show 11 earlier versionsHide 11 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Study sites: 24 to 19 · Primary completion date: Apr 2026 to Oct 2026 · Completion date: Sep 2026 to Oct 2026 · 2 morev12 Show 5 more changesShow less
    • Study sites: 24 to 19
    • Primary completion date: Apr 2026 to Oct 2026
    • Completion date: Sep 2026 to Oct 2026
    • Secondary endpoints: 6 to 4
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 23 to 24v11
  3. Study sites: 17 to 23v10
  4. Study sites: 22 to 17v9
  5. Study sites revised (22)v8 See this version in full on ClinicalTrials.gov ↗
  6. Primary completion date: Sep 2024 to Apr 2026 Enrollment target: 180 to 202 · Completion date: Aug 2025 to Sep 2026 · Eligibility criteria expanded, about 68 words · 2 morev7 Show 5 more changesShow less
    • Enrollment target: 180 to 202
    • Completion date: Aug 2025 to Sep 2026
    • Eligibility criteria expanded, about 68 words
    • Secondary endpoints: 9 to 6
    • Study arms: 6 to 9

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 23 to 22v6
  8. Re-verified, no change to tracked fieldsv5
  9. Study sites: 22 to 23v4
  10. Study sites: 1 to 22v3
  11. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jan 2023 to Jan 19, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2023 to Jan 19, 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
BeiGene
37 trials monitored
See 1 trial at risk
Melanoma
1,026 trials monitored
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Kidney Cancer
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The objective of this study is to assess the overall response rate, evaluate the antitumor activity, and characterize the safety and tolerability of BGB-A445 alone or in combination with tislelizumab in participants With Advanced or Metastatic Urothelial Carcinoma (UC), Renal Cell Carcinoma (RCC), or Melanoma
Trial Details
NCT Number NCT05661955
Lead Sponsor BeiGene
Conditions Urothelial Carcinoma, Renal Cell Carcinoma, Melanoma, Non-mucosal Melanoma
Enrollment 113 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov