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Purpose

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

Conditions

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.