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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.

Primary Purpose

Urothelial Carcinoma, Renal Cell Carcinoma, Melanoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BGB-A445
Tislelizumab
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Carcinoma focused on measuring Urothelial Carcinoma, Renal Cell Carcinoma, Melanoma, advanced solid tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants described in the following cohorts, who have received at least 1 but no more than 3 lines of prior systemic therapy for histologically or cytologically confirmed advanced and/or metastatic UC, RCC or melanoma 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) 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

Sites / Locations

  • Peking University First HospitalRecruiting
  • Beijing Cancer HospitalRecruiting
  • Fujian Cancer HospitalRecruiting
  • Lanzhou University Second HospitalRecruiting
  • Zhujiang Hospital of Southern Medical UniversityRecruiting
  • Sun Yat Sen University Cancer CenterRecruiting
  • The Tumor Hospital Affiliated to Guangxi Medical UniversityRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • The Third Peoples Hospital of ZhengzhouRecruiting
  • Tongji Hospital of Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical SchoolRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Liaoning Cancer Hospital and InstituteRecruiting
  • Shandong Cancer HospitalRecruiting
  • Jining No Peoples Hospital Main BranchRecruiting
  • Shanxi Provincial Cancer HospitalRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • The Second Affiliated Hospital of Tianjin Medical UniversityRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Previously Treated UC Cohort A

Previously Treated UC Cohort B

Previously Treated RCC Cohort C

Previously Treated RCC Cohort D

Previously Treated Melanoma Cohort E

Previously Treated Melanoma Cohort F

Arm Description

BGB-A445 Monotherapy

BGB-A445 and Tislelizumab

BGB-A445 Monotherapy

BGB-A445 and Tislelizumab

BGB-A445 Monotherapy

BGB-A445 and Tislelizumab

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR) as Assessed by the Investigator
ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)

Secondary Outcome Measures

Progression-free survival (PFS)
Determined from investigator derived tumor assessments as per RECIST 1.1
Duration of Response (DOR)
Determined from investigator derived tumor assessments as per RECIST 1.1
Disease-Control Rate (DCR)
Determined from investigator derived tumor assessments as per RECIST 1.1
Clinical benefit rate (CBR)
Determined from investigator derived tumor assessments as per RECIST 1.1
Number of Participants Experiencing Adverse Events (AEs)
As determined per National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), physical examinations, electrocardiograms (ECGs), and laboratory assessments as needed
Number of Participants Experiencing Serious Adverse Events (SAEs)
As determined per National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), physical examinations, electrocardiograms (ECGs), and laboratory assessments as needed
Serum Concentration of BGB-A445
Serum Concentration of tislelizumab
Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies

Full Information

First Posted
December 15, 2022
Last Updated
August 10, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT05661955
Brief Title
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.
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma, Renal Cell Carcinoma, Melanoma
Keywords
Urothelial Carcinoma, Renal Cell Carcinoma, Melanoma, advanced solid tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Previously Treated UC Cohort A
Arm Type
Experimental
Arm Description
BGB-A445 Monotherapy
Arm Title
Previously Treated UC Cohort B
Arm Type
Experimental
Arm Description
BGB-A445 and Tislelizumab
Arm Title
Previously Treated RCC Cohort C
Arm Type
Experimental
Arm Description
BGB-A445 Monotherapy
Arm Title
Previously Treated RCC Cohort D
Arm Type
Experimental
Arm Description
BGB-A445 and Tislelizumab
Arm Title
Previously Treated Melanoma Cohort E
Arm Type
Experimental
Arm Description
BGB-A445 Monotherapy
Arm Title
Previously Treated Melanoma Cohort F
Arm Type
Experimental
Arm Description
BGB-A445 and Tislelizumab
Intervention Type
Drug
Intervention Name(s)
BGB-A445
Intervention Description
administered intravenously
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
administered intravenously
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) as Assessed by the Investigator
Description
ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
Time Frame
Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Determined from investigator derived tumor assessments as per RECIST 1.1
Time Frame
Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Title
Duration of Response (DOR)
Description
Determined from investigator derived tumor assessments as per RECIST 1.1
Time Frame
Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Title
Disease-Control Rate (DCR)
Description
Determined from investigator derived tumor assessments as per RECIST 1.1
Time Frame
Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Title
Clinical benefit rate (CBR)
Description
Determined from investigator derived tumor assessments as per RECIST 1.1
Time Frame
Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Title
Number of Participants Experiencing Adverse Events (AEs)
Description
As determined per National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), physical examinations, electrocardiograms (ECGs), and laboratory assessments as needed
Time Frame
Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Title
Number of Participants Experiencing Serious Adverse Events (SAEs)
Description
As determined per National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), physical examinations, electrocardiograms (ECGs), and laboratory assessments as needed
Time Frame
Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Title
Serum Concentration of BGB-A445
Time Frame
60 minutes predose up to 72 hours postdose
Title
Serum Concentration of tislelizumab
Time Frame
60 minutes predose up to 72 hours postdose
Title
Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies
Time Frame
Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants described in the following cohorts, who have received at least 1 but no more than 3 lines of prior systemic therapy for histologically or cytologically confirmed advanced and/or metastatic UC, RCC or melanoma 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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BeiGene
Phone
1.877.828.5568
Email
clinicaltrials@beigene.com
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
The Tumor Hospital Affiliated to Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Peoples Hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450099
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Liaoning Cancer Hospital and Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Name
Jining No Peoples Hospital Main Branch
City
Jining
State/Province
Shandong
ZIP/Postal Code
272002
Country
China
Individual Site Status
Recruiting
Facility Name
Shanxi Provincial Cancer Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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.

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