Clinical trial 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.
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Urothelial Carcinoma
Renal Cell Carcinoma
Melanoma
Non-mucosal Melanoma
Keywords: Urothelial Carcinoma
Renal Cell Carcinoma
Melanoma
Advanced solid tumors
Non-mucosal melanoma
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2022-12-22
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Key Inclusion Criteria:

1. 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.
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)

Key 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

Primary outcomes:
measure: Overall Response Rate (ORR) as Assessed by the Investigator
timeFrame: 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 outcomes:
measure: Disease-Control Rate (DCR)
timeFrame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
measure: Clinical benefit rate (CBR)
timeFrame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
measure: Number of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Lanzhou
country: China
facility: The Second Hospital and Clinical Medical School, Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: The Tumor Hospital Affiliated to Guangxi Medical University
state: Guangxi
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Jining
country: China
facility: Jining No Peoples Hospital West Branch
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: