A Study in Patients With Advanced Cancers
Sponsor: BiOneCure Therapeutics Inc.
ClinicalTrials ID:NCT05320588
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
| Parameter | Options |
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| NEXT Oncology Austin | 78758 | Austin | Texas |
| University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
| NEXT Oncology Virginia | 22031 | Fairfax | Virginia |
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