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.

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05661955
• Other study ID #: BGB-A317-A445-201
• Secondary ID: CTR20223270
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 19, 2023
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: BeiGene
• Contact: BeiGene
• Phone: 1.877.828.5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Has at least 1 measurable lesion as defined per RECIST v1.1.

3. Participants must be able to provide an archived formalin-fixed paraffin embedded (FFPE) tumor tissue sample

4. ECOG PS = 1 (Participants with UC could have an ECOG PS = 2) and a life expectancy of= 3 months

5. Adequate organ function as indicated by the laboratory values up to the first dose of study drug(s)

Exclusion Criteria:

1. Active leptomeningeal disease or uncontrolled brain metastasis

2. Active autoimmune diseases or history of autoimmune diseases that may relapse or history of life-threatening toxicity related to prior immune therapy

3. 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

4. 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:

1. Adrenal replacement steroid (dose = 10 mg daily of prednisone or equivalent)

2. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption

3. 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)

5. 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Carcinoma, Transitional Cell
• Melanoma
• Renal Cell Carcinoma
• Urothelial Carcinoma

Intervention

Drug:
• BGB-A445
administered intravenously
• Tislelizumab
administered intravenously

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Sun Yat Sen University Cancer Center	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Shandong Cancer Hospital	Jinan	Shandong
China	Jining No Peoples Hospital Main Branch	Jining	Shandong
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	The Tumor Hospital Affiliated to Guangxi Medical University	Nanning	Guangxi
China	Liaoning Cancer Hospital and Institute	Shenyang	Liaoning
China	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi
China	The Second Affiliated Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	Progression-free survival (PFS)	Determined from investigator derived tumor assessments as per RECIST 1.1	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	Duration of Response (DOR)	Determined from investigator derived tumor assessments as per RECIST 1.1	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	Disease-Control Rate (DCR)	Determined from investigator derived tumor assessments as per RECIST 1.1	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	Clinical benefit rate (CBR)	Determined from investigator derived tumor assessments as per RECIST 1.1	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	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	Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Secondary	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	Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Secondary	Serum Concentration of BGB-A445		60 minutes predose up to 72 hours postdose
Secondary	Serum Concentration of tislelizumab		60 minutes predose up to 72 hours postdose
Secondary	Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies		Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first