Recruiting
Phase 1
Phase 2

BIO-106 & Pembrolizumab

Sponsor:

BiOneCure Therapeutics Inc.

Code:

NCT05320588

Conditions

Advanced Cancer

Advanced Solid Tumor

Cancer

Oncology

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BIO-106

Pembrolizumab

Study Details

Brief summary:

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

Study ID

NCT05320588

Start date

Mar 25, 2022

Status verified date

Jul, 2022

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

332 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single agent BIO-106

Escalating doses followed by expansion targeting advanced cancers

experimental: Combination BIO-106 plus pembrolizumab

Escalating doses followed by expansion targeting advanced cancers

Interventions

BIO-106

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

Pembrolizumab

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

Primary outcome measure

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) [ Time Frame: 1 year ]
  • Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1) [ Time Frame: up to 21 days ]
  • Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) [ 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) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

BiOneCure Therapeutics Inc.

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

Locations

NEXT Oncology Austin

Recruiting

Austin, Texas, United States, 78758

Contacts

Cynthia DeLeon

210-580-9521cdeleon@nextoncology.com

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Funda Meric-Bernstam, MD

832-483-8248fmeric@mdanderson.org

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Malaika Komtangi

210-580-9500mkomtangi@nextoncology.com

More Information

Sponsor

BiOneCure Therapeutics Inc.

Last update posted

Jul 19, 2022

Last verified

Jul, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BiOneCure Therapeutics Inc. on 2022-07-19.