A Study in Patients With Advanced Cancers

BiOneCure Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Cancer; Oncology; Advanced Solid Tumor; Cancer

Treatments: Drug: Pembrolizumab; Drug: BIO-106

Study type: Interventional

Funder types: Industry

Identifiers

NCT05320588

StarBridge-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 332 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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332 participants in 2 patient groups

Single agent BIO-106

Experimental group

Description:

Escalating doses followed by expansion targeting advanced cancers

Treatment:

Drug: BIO-106

Combination BIO-106 plus pembrolizumab

Experimental group

Description:

Escalating doses followed by expansion targeting advanced cancers

Treatment:

Drug: Pembrolizumab

Drug: BIO-106