A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)
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.
Arms & interventions
- DrugBIO-106
BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)
- DrugPembrolizumab
Programmed death receptor-1 (PD 1)-blocking antibody
Outcome measures
Primary
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
Escalation period
Time frame: 1 year
Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)
Escalation period
Time frame: up to 21 days
Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)
Escalation period
Time frame: 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
Time frame: 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)
Time frame: 1 year
Incidence of adverse event of special interest (AESI) - (Phase 2)
Time frame: 2 years
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)
Time frame: 2 years
PK (Cmax) of BIO-106 - (Phase 1/2)
Time frame: 2 years
PK (AUC) of BIO-106 - (Phase 1/2)
Time frame: 2 years
Incidence of anti-BIO-106 antibodies - (Phase 1/2)
Time frame: 2 years
Eligibility criteria
Study locations (3)
NEXT Oncology Austin
Austin, Texas, 78758
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
NEXT Oncology Virginia
Fairfax, Virginia, 22031