A Study in Patients With Advanced Cancers

Status: active

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

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. Key

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. Other protocol defined inclusion/exclusion criteria may apply.

This is an open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and

dose-expansion study of BIO-106 administered as monotherapy and in combination with

pembrolizumab. Phase 1 will define the maximum tolerated dose (MTD) or recommended Phase

2 dose (RP2D) of BIO-106 that can be advanced to Phase 2. Phase 2 will define the

preliminary efficacy of these regimens in the setting of advanced solid tumors with high

unmet medical needs.

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