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NCT05320588PHASE1, PHASE2Recruiting

A Study in Patients With Advanced Cancers

BiOneCure Therapeutics Inc.

Start Date

3/25/2022

Completion Date

4/1/2027

Summary

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

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Interventions

DRUG

BIO-106

DRUG

Pembrolizumab

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Conditions

Advanced CancerAdvanced Solid TumorCancerOncology

Locations

NEXT Oncology Austin

Austin, Texas 78758

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

NEXT Oncology Virginia

Fairfax, Virginia 22031

United States