A Study in Patients With Advanced Cancers

Sponsor: BiOneCure Therapeutics Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05320588

Patient View

This open-label Phase 1/2 study evaluates BIO-106, a novel ADC targeting Trop-2, alone and with pembrolizumab. Phase 1 identifies the MTD/RP2D, while Phase 2 assesses efficacy in advanced solid tumors. Eligible patients have progressed or refractory tumors, measurable disease, and ECOG 0-1.

Patient Parameters

Program Overview

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

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

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.

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