A Study in Patients With Advanced Cancers

Description

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

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Study Overview

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Study Details

Study overview

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

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

A Study in Patients With Advanced Cancers

Condition
Advanced Cancer
Intervention / Treatment

-

Contacts and Locations

Austin

NEXT Oncology Austin, Austin, Texas, United States, 78758

Houston

University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Fairfax

NEXT Oncology Virginia, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * History of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BiOneCure Therapeutics Inc.,

BiOneCure Clinical Development, STUDY_DIRECTOR, BiOneCure Therapeutics Inc.

Study Record Dates

2027-04