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Study of BIO-106 and Pembrolizumab for Advanced Cancers

This study is testing two medicines, BIO-106 and pembrolizumab, for people with advanced cancers. BIO-106 is a new type of drug called an antibody-drug conjugate (ADC) that targets a protein called Trop-2 on cancer cells. Pembrolizumab is a drug that helps your immune system fight cancer. You might be able to join if you have a locally advanced or metastatic solid tumor that has gotten worse after standard treatments, or if you can't tolerate or have reasons not to use standard treatments. The main goals are to see how safe these drugs are, find the right dose, and understand their effects. The study is currently unclear on its recruitment status.

Study design
This is an open-label (meaning you and your doctors will know which treatment you are receiving), Phase 1/2 study. It plans to enroll 332 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured for up to 1 year, and dose-limiting toxicities (side effects that are severe enough to limit the dose) will be measured for up to 21 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05320588

A Study in Patients With Advanced Cancers

Recruiting
PHASE1Ages 18+InterventionalTreatment
BiOneCure Therapeutics Inc.
~332 participants
Updated 2022-07-19 on ClinicalTrials.gov
What's tested:BIO-106Pembrolizumab

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
Measured over 1 year
+3 more outcomes measured

Conditions

Advanced Cancer
Advanced Solid Tumor
Cancer
Oncology

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Solid Neoplasm

NCT05320588

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • NEXT Oncology Austin

    Austin, Texasstudy coordinator listed

    Recruiting

  • NEXT Oncology Virginia

    Fairfax, Virginiastudy coordinator listed

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • BiOneCure Clinical Development · STUDY_DIRECTOR · BiOneCure Therapeutics Inc.

Who to contact

BiOneCure Therapeutics Inc.
[email protected]
(240) 912-9101
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)1 year

    Escalation period

  • Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)up to 21 days

    Escalation period

  • Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)1 year

    Escalation period

  • 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)2 years

    Expansion period