A Study in Patients With Advanced Cancers

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

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

Study Overview

• Status: Recruiting
• Conditions: Cancer; Advanced Solid Tumor; Advanced Cancer; Oncology
• Intervention / Treatment: Drug: BIO-106; Drug: Pembrolizumab

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 Type: Interventional
• Enrollment (Anticipated): 332
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: BiOneCure Therapeutics Inc.; Phone Number: (240) 912-9101; Email: Starbridge-1@bionecure.com

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78758
      • Recruiting
      • Next Oncology Austin
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center
      • Contact: Funda Meric-Bernstam, MD; Phone Number: 832-483-8248; Email: fmeric@mdanderson.org
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • NEXT Oncology Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Keytruda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Escalation Period	1 year
Incidence of adverse event of special interest (AESI) - (Phase 2)	Expansion period	2 years
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)	Expansion period	2 years
PK (Cmax) of BIO-106 - (Phase 1/2)	Escalation and expansion periods	2 years
PK (AUC) of BIO-106 - (Phase 1/2)	Escalation and expansion periods	2 years
Incidence of anti-BIO-106 antibodies - (Phase 1/2)	Escalation and expansion periods	2 years

Collaborators and Investigators

• Sponsor: BiOneCure Therapeutics Inc.
• Investigators: Study Director: BiOneCure Clinical Development, BiOneCure Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 25, 2022
• Primary Completion (ANTICIPATED): April 1, 2024
• Study Completion (ANTICIPATED): April 1, 2027

Study Registration Dates

• First Submitted: April 2, 2022
• First Submitted That Met QC Criteria: April 2, 2022
• First Posted (ACTUAL): April 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Pembrolizumab
• Other Study ID Numbers: StarBridge-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No