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Active, Not Recruiting

NCT Number: NCT05661955

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.

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Participants who were histologically or cytologically confirmed advanced and/or metastatic cancer. UC participants (Cohort A and B), RCC patients (Cohort C and D) or melanoma participants (Cohort E and F) who have received at least 1 but no more than 3 lines of prior systemic therapy. Cisplatin ineligible UC participants (Cohort G) who have received no prior systemic therapy and have PD-L1 CPS ≥ 10. Melanoma patients (Cohort H) with non-mucosal melanoma who have no previous systemic treatment. Melanoma participants (Cohort I) with non-mucosal melanoma who were CPI pretreated and have 1 or 2 lines of prior systemic therapy. Participants must not have received prior therapy targeting OX40 or any other T-cell agonists.
  • Has at least 1 measurable lesion as defined per RECIST v1.1.
  • Participants must be able to provide an archived formalin-fixed paraffin embedded (FFPE) tumor tissue sample
  • ECOG PS ≤ 1 (Participants with UC could have an ECOG PS ≤ 2) and a life expectancy of≥ 3 months
  • Adequate organ function as indicated by the laboratory values up to the first dose of study drug(s)

Key Exclusion Criteria:

  • Active leptomeningeal disease or uncontrolled brain metastasis
  • Active autoimmune diseases or history of autoimmune diseases that may relapse or history of life-threatening toxicity related to prior immune therapy
  • Any active malignancy ≤ 2 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
  • Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s), with the following exceptions:
  • Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
  • Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption
  • Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a nonautoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)
  • With uncontrolled diabetes, or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia occurring ≤ 14 days before the first dose of study drug(s)

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

BGB-A445

Drug

administered intravenously

Other names: Gimistotug

Tislelizumab

Drug

administered intravenously

Other names: BGB-A317

Primary outcomes

  1. Overall Response Rate (ORR) as Assessed by the Investigator

    Time frame: Up to approximately 26 months

    ORR is defined as the percentage of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)

Secondary outcomes

  1. Disease-Control Rate (DCR)

    Time frame: Up to approximately 26 months

    DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments by the investigator using RECIST v1.1.

  2. Clinical Benefit Rate (CBR)

    Time frame: Up to approximately 26 months

    CBR is defined as the percentage of participants with best overall response of CR, PR, or stable disease lasting for at least 24 weeks as determined from tumor assessments by the investigator using RECIST v1.1.

  3. Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 30 days after the last dose of study drugs or the initiation of new anticancer therapy, whichever comes earlier, up to 22 months

    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) as needed

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

Phase 1b/2 Study Investigating the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of the Anti-OX40 Agonist Monoclonal Antibody BGB-A445 in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Urothelial Carcinoma, Renal Cell Carcinoma, or Melanoma

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 22, 2022
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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