RecruitingPhase 1Phase 2NCT05320588

A Study in Patients With Advanced Cancers

A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)

Sponsor

BiOneCure Therapeutics Inc.

Enrollment

332 participants

Start Date

Mar 25, 2022

Study Type

INTERVENTIONAL

Conditions

A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.

Min Age: 18 Years

Patients histologically or cytologically documented, locally advanced or metastatic solid tumor.
Disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment.
Measurable disease as determined by RECIST v.1.1 or bone only disease.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

History of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody.
Impaired cardiac function or history of clinically significant cardiac disease
Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
Active SARS-CoV-2 infection.
Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.

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