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.

Sponsor

BeiGene (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05661955

Collaborator

(none)

180

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Urothelial Carcinoma Renal Cell Carcinoma Melanoma	Drug: BGB-A445 Drug: Tislelizumab	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Previously Treated UC Cohort A BGB-A445 Monotherapy	Drug: BGB-A445 administered intravenously
Experimental: Previously Treated UC Cohort B BGB-A445 and Tislelizumab	Drug: BGB-A445 administered intravenously Drug: Tislelizumab administered intravenously
Experimental: Previously Treated RCC Cohort C BGB-A445 Monotherapy	Drug: BGB-A445 administered intravenously
Experimental: Previously Treated RCC Cohort D BGB-A445 and Tislelizumab	Drug: BGB-A445 administered intravenously Drug: Tislelizumab administered intravenously
Experimental: Previously Treated Melanoma Cohort E BGB-A445 Monotherapy	Drug: BGB-A445 administered intravenously
Experimental: Previously Treated Melanoma Cohort F BGB-A445 and Tislelizumab	Drug: BGB-A445 administered intravenously Drug: Tislelizumab administered intravenously

Outcome Measures

Primary Outcome Measures

Overall Response Rate (ORR) as Assessed by the Investigator [Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first]
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) [Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first]
Determined from investigator derived tumor assessments as per RECIST 1.1
Duration of Response (DOR) [Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first]
Determined from investigator derived tumor assessments as per RECIST 1.1
Disease-Control Rate (DCR) [Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first]
Determined from investigator derived tumor assessments as per RECIST 1.1
Clinical benefit rate (CBR) [Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first]
Determined from investigator derived tumor assessments as per RECIST 1.1
Number of Participants Experiencing Adverse Events (AEs) [Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy]
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) [Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy]
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 [60 minutes predose up to 72 hours postdose]
Serum Concentration of tislelizumab [60 minutes predose up to 72 hours postdose]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)