Clinical trial NCT05320588: A Study in Patients With Advanced Cancers
Official title: A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Advanced Solid Tumor
Cancer
Oncology
Lead sponsor: BiOneCure Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multiple ascending dose and dose-expansion of BIO-106 administered as a single agent or in combination with pembrolizumab.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
timeFrame: 1 year
measure: Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)
timeFrame: up to 21 days
measure: Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)
timeFrame: 1 year
measure: 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)
timeFrame: 2 years
Secondary outcomes:
measure: 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)
timeFrame: 1 year
measure: Incidence of adverse event of special interest (AESI) - (Phase 2)
timeFrame: 2 years
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)
timeFrame: 2 years
measure: PK (Cmax) of BIO-106 - (Phase 1/2)
timeFrame: 2 years
measure: PK (AUC) of BIO-106 - (Phase 1/2)
timeFrame: 2 years
measure: Incidence of anti-BIO-106 antibodies - (Phase 1/2)
timeFrame: 2 years
Other outcomes:
Locations:
city: Austin
country: United States
facility: NEXT Oncology Austin
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: NEXT Oncology Virginia
state: Virginia
Study officials:
affiliation: BiOneCure Therapeutics Inc.
name: BiOneCure Clinical Development
role: STUDY_DIRECTOR
References: