A Study in Patients With Advanced Cancers

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05320588
• Other study ID #: StarBridge-1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 25, 2022
• Est. completion date: April 2027

Study information

• Verified date: July 2022
• Source: BiOneCure Therapeutics Inc.
• Contact: BiOneCure Therapeutics Inc.
• Phone: (240) 912-9101
• Email: Starbridge-1[@]bionecure.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 332
• Est. completion date: April 2027
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Advanced Solid Tumor
• Cancer
• Neoplasms
• Oncology

Intervention

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

Locations

Country	Name	City	State
United States	NEXT Oncology Austin	Austin	Texas
United States	NEXT Oncology Virginia	Fairfax	Virginia
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
BiOneCure Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)	Escalation period	1 year
Primary	Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)	Escalation period	up to 21 days
Primary	Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)	Escalation period	1 year
Primary	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	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
Secondary	Incidence of adverse event of special interest (AESI) - (Phase 2)	Expansion period	2 years
Secondary	Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)	Expansion period	2 years
Secondary	PK (Cmax) of BIO-106 - (Phase 1/2)	Escalation and expansion periods	2 years
Secondary	PK (AUC) of BIO-106 - (Phase 1/2)	Escalation and expansion periods	2 years
Secondary	Incidence of anti-BIO-106 antibodies - (Phase 1/2)	Escalation and expansion periods	2 years