RECRUITING

A Study in Patients With Advanced Cancers

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Conditions

Advanced CancerAdvanced Solid TumorCancerOncology

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-03-25
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05320588

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients histologically or cytologically documented, locally advanced or metastatic solid tumor.
  2. * 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.
  3. * Measurable disease as determined by RECIST v.1.1 or bone only disease.
  4. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  1. * History of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody.
  2. * Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
  3. * Active SARS-CoV-2 infection.
  4. * Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.

Contacts and Locations

Study Contact

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

Principal Investigator

BiOneCure Clinical Development
STUDY_DIRECTOR
BiOneCure Therapeutics Inc.

Study Locations (Sites)

NEXT Oncology Austin
Austin, Texas, 78758
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
NEXT Oncology Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: BiOneCure Therapeutics Inc.

  • BiOneCure Clinical Development, STUDY_DIRECTOR, BiOneCure Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-25
Study Completion Date2027-04

Study Record Updates

Study Start Date2022-03-25
Study Completion Date2027-04

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Cancer
  • Advanced Solid Tumor
  • Cancer
  • Oncology