Clinical Trials/NCT05661955

NCT05661955

Active, Not Recruiting

Phase 1

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

BeiGene33 sites in 1 country113 target enrollmentJanuary 9, 2023

ConditionsUrothelial Carcinoma Renal Cell Carcinoma Melanoma Non-mucosal Melanoma

InterventionsBGB-A445 Tislelizumab

DrugsBGB-A445 Tislelizumab

Overview

Phase: Phase 1
Intervention: BGB-A445
Conditions: Urothelial Carcinoma
Sponsor: BeiGene
Enrollment: 113
Locations: 33
Primary Endpoint: Overall Response Rate (ORR) as Assessed by the Investigator
Status: Active, Not Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 9, 2023

End Date

October 1, 2026

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

BeiGene

Responsible Party

Sponsor

Eligibility Criteria

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 ≥
•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.
•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)

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

Arms & Interventions

Cohort A: Previously Treated UC

BGB-A445 Monotherapy

Intervention: BGB-A445

Cohort B: Previously Treated UC

BGB-A445 and Tislelizumab

Intervention: BGB-A445

Cohort B: Previously Treated UC

BGB-A445 and Tislelizumab

Intervention: Tislelizumab

Cohort C: Previously Treated RCC

BGB-A445 Monotherapy

Intervention: BGB-A445

Cohort D: Previously Treated RCC

BGB-A445 and Tislelizumab

Intervention: BGB-A445

Cohort D: Previously Treated RCC

BGB-A445 and Tislelizumab

Intervention: Tislelizumab

Cohort E: Previously Treated Melanoma

BGB-A445 Monotherapy

Intervention: BGB-A445

Cohort F: Previously Treated Melanoma

BGB-A445 and Tislelizumab

Intervention: BGB-A445

Cohort F: Previously Treated Melanoma

BGB-A445 and Tislelizumab

Intervention: Tislelizumab

Cohort G: First Line Cisplatin Ineligible UC

BGB-A445 and Tislelizumab

Intervention: BGB-A445

Cohort G: First Line Cisplatin Ineligible UC

BGB-A445 and Tislelizumab

Intervention: Tislelizumab

Cohort H: First Line Non-mucosal Melanoma

BGB-A445 and Tislelizumab

Intervention: BGB-A445

Cohort H: First Line Non-mucosal Melanoma

BGB-A445 and Tislelizumab

Intervention: Tislelizumab

Cohort I: Previously Treated Non-mucosal Melanoma

BGB-A445 and Tislelizumab

Intervention: BGB-A445

Cohort I: Previously Treated Non-mucosal Melanoma

BGB-A445 and Tislelizumab

Intervention: Tislelizumab

Outcomes

Primary Outcomes

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

Disease-Control Rate (DCR)(Up to approximately 26 months)
Clinical Benefit Rate (CBR)(Up to approximately 26 months)
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)(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)