Advanced Cancer, Advanced Solid Tumor, Cancer, Oncology
Conditions
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.
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
Sponsors
BiOneCure Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multiple ascending dose and dose-expansion of BIO-106 administered as a single agent or in combination with pembrolizumab.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) | 1 year | Escalation period |
| Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1) | up to 21 days | Escalation period |
| Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) | 1 year | Escalation period |
| 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) | 2 years | Expansion period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK (AUC) of BIO-106 - (Phase 1/2) | 2 years | Escalation and expansion periods |
| 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 | Escalation Period |
| Incidence of anti-BIO-106 antibodies - (Phase 1/2) | 2 years | Escalation and expansion periods |
| Incidence of adverse event of special interest (AESI) - (Phase 2) | 2 years | Expansion period |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2) | 2 years | Expansion period |
| PK (Cmax) of BIO-106 - (Phase 1/2) | 2 years | Escalation and expansion periods |
Countries
United States
Contacts
Primary ContactBiOneCure Therapeutics Inc.
Outcome results
None listed