NCT05320588

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
332

participants targeted

Target at P75+ for phase_1

Timeline
11mo left

Started Mar 2022

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Mar 2022Apr 2027

Study Start

First participant enrolled

March 25, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

April 2, 2022

Last Update Submit

July 15, 2022

Conditions

Advanced CancerAdvanced Solid TumorCancerOncology

Outcome Measures

Primary Outcomes (4)

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

    Escalation period

    1 year

  • Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)

    Escalation period

    up to 21 days

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

    Escalation period

    1 year

  • 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)

    Expansion period

    2 years

Secondary Outcomes (6)

  • 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)

    1 year

  • Incidence of adverse event of special interest (AESI) - (Phase 2)

    2 years

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)

    2 years

  • PK (Cmax) of BIO-106 - (Phase 1/2)

    2 years

  • PK (AUC) of BIO-106 - (Phase 1/2)

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Single agent BIO-106

EXPERIMENTAL

Escalating doses followed by expansion targeting advanced cancers

Drug: BIO-106

Combination BIO-106 plus pembrolizumab

EXPERIMENTAL

Escalating doses followed by expansion targeting advanced cancers

Drug: BIO-106Drug: Pembrolizumab

Interventions

BIO-106DRUG

BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)

Combination BIO-106 plus pembrolizumabSingle agent BIO-106
PembrolizumabDRUG

Programmed death receptor-1 (PD 1)-blocking antibody

Also known as: Keytruda
Combination BIO-106 plus pembrolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NEXT Oncology Austin

Austin, Texas, 78758, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

pembrolizumab

Study Officials

  • BiOneCure Clinical Development

    BiOneCure Therapeutics Inc.

    STUDY DIRECTOR

Central Study Contacts

BiOneCure Therapeutics Inc.

CONTACT

(240) 912-9101Starbridge-1@bionecure.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Multiple ascending dose and dose-expansion of BIO-106 administered as a single agent or in combination with pembrolizumab.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2022

First Posted

April 11, 2022

Study Start

March 25, 2022

Primary Completion

April 1, 2024

Study Completion (Estimated)

April 1, 2027

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(3)