A Study in Patients With Advanced Cancers

Part of paid clinical trials in Austin, Texas.

Sponsor
BiOneCure Therapeutics Inc.
Study ID
NCT05320588
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Advanced Solid Tumor
  • Cancer
  • Oncology

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BIO-106 — DRUG
    BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)
  • Pembrolizumab — DRUG
    Programmed death receptor-1 (PD 1)-blocking antibody

Study Details

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

Key Dates

Start date
Mar 25, 2022
Status verified
Jul 2022
Primary completion
Apr 30, 2024
Completion
Apr 30, 2027

Study Design

Enrollment
332 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) [ Time Frame: 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
NEXT Oncology AustinAustinTexas78758
Cynthia DeLeon
[email protected]
210-580-9521
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Funda Meric-Bernstam, MD
[email protected]
832-483-8248
NEXT Oncology VirginiaFairfaxVirginia22031
Malaika Komtangi
[email protected]
210-580-9500

Find similar trials in Austin, TX

By research site
NEXT Oncology Austin· Austin, TXUniversity of Texas MD Anderson Cancer Center· Houston, TXNEXT Oncology Virginia· Fairfax, VA

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