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A Study in Patients With Advanced Cancers

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ClinicalTrials.gov Identifier: NCT05320588
Recruitment Status : Recruiting
First Posted : April 11, 2022
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
BiOneCure Therapeutics Inc.

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

Condition or disease Intervention/treatment Phase
Advanced Cancer Advanced Solid Tumor Cancer Oncology Drug: BIO-106 Drug: Pembrolizumab Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)
Actual Study Start Date : March 25, 2022
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: Keytruda


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) [ Time Frame: 1 year ]
    Escalation period

  2. Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1) [ Time Frame: up to 21 days ]
    Escalation period

  3. Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) [ Time Frame: 1 year ]
    Escalation period

  4. 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 ]
    Expansion period


Secondary Outcome Measures :
  1. 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 1) [ Time Frame: 1 year ]
    Escalation Period

  2. Incidence of adverse event of special interest (AESI) - (Phase 2) [ Time Frame: 2 years ]
    Expansion period

  3. Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2) [ Time Frame: 2 years ]
    Expansion period

  4. PK (Cmax) of BIO-106 - (Phase 1/2) [ Time Frame: 2 years ]
    Escalation and expansion periods

  5. PK (AUC) of BIO-106 - (Phase 1/2) [ Time Frame: 2 years ]
    Escalation and expansion periods

  6. Incidence of anti-BIO-106 antibodies - (Phase 1/2) [ Time Frame: 2 years ]
    Escalation and expansion periods


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05320588


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

Locations
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United States, Texas
NEXT Oncology Austin Recruiting
Austin, Texas, United States, 78758
Contact: Cynthia DeLeon    210-580-9521    cdeleon@nextoncology.com   
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Funda Meric-Bernstam, MD    832-483-8248    fmeric@mdanderson.org   
United States, Virginia
NEXT Oncology Virginia Recruiting
Fairfax, Virginia, United States, 22031
Contact: Malaika Komtangi    210-580-9500    mkomtangi@nextoncology.com   
Sponsors and Collaborators
BiOneCure Therapeutics Inc.
Investigators
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Study Director: BiOneCure Clinical Development BiOneCure Therapeutics Inc.
More Information
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Responsible Party: BiOneCure Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05320588    
Other Study ID Numbers: StarBridge-1
First Posted: April 11, 2022    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents