A Study in Patients With Advanced Cancers

Purpose

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

Conditions

  • Advanced Cancer
  • Advanced Solid Tumor
  • Cancer
  • Oncology

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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 Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Multiple ascending dose and dose-expansion of BIO-106 administered as a single agent or in combination with pembrolizumab.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Single agent BIO-106 		Escalating doses followed by expansion targeting advanced cancers
  • Drug: BIO-106
    BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)
Experimental
Combination BIO-106 plus pembrolizumab 		Escalating doses followed by expansion targeting advanced cancers
  • Drug: BIO-106
    BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)
  • Drug: Pembrolizumab
    Programmed death receptor-1 (PD 1)-blocking antibody
    Other names:
    • Keytruda

Recruiting Locations

NEXT Oncology Austin
Austin 4671654, Texas 4736286 78758
Contact:
Cynthia DeLeon
210-580-9521
cdeleon@nextoncology.com

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Funda Meric-Bernstam, MD
832-483-8248
fmeric@mdanderson.org

NEXT Oncology Virginia
Fairfax 4758023, Virginia 6254928 22031
Contact:
Malaika Komtangi
210-580-9500
mkomtangi@nextoncology.com

More Details

Status
Recruiting
Sponsor
BiOneCure Therapeutics Inc.

Study Contact

BiOneCure Therapeutics Inc.
(240) 912-9101
Starbridge-1@bionecure.com

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.