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RecruitingInterventionalPhase 1/Phase 2

A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)

NCT ID: NCT05320588Sponsor: BiOneCure Therapeutics Inc.Last updated: 2022-07-19

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.

Arms & interventions

  • DrugBIO-106

    BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)

  • DrugPembrolizumab

    Programmed death receptor-1 (PD 1)-blocking antibody

Outcome measures

Primary

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)

    Escalation period

    Time frame: 1 year

  • Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)

    Escalation period

    Time frame: up to 21 days

  • Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)

    Escalation period

    Time frame: 1 year

  • Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 2)

    Expansion period

    Time frame: 2 years

Secondary

  • Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 1)

    Time frame: 1 year

  • Incidence of adverse event of special interest (AESI) - (Phase 2)

    Time frame: 2 years

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)

    Time frame: 2 years

  • PK (Cmax) of BIO-106 - (Phase 1/2)

    Time frame: 2 years

  • PK (AUC) of BIO-106 - (Phase 1/2)

    Time frame: 2 years

  • Incidence of anti-BIO-106 antibodies - (Phase 1/2)

    Time frame: 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (3)

NEXT Oncology Austin

Austin, Texas, 78758

Recruiting
Cynthia DeLeon · Contact

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Funda Meric-Bernstam, MD · Contact

NEXT Oncology Virginia

Fairfax, Virginia, 22031

Recruiting
Malaika Komtangi · Contact
A Study in Patients With Advanced Cancers | Cancerify