A Study in Patients With Advanced Cancers

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

Detailed Description
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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.

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

Conditions
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Advanced Cancer, Advanced Solid Tumor, Cancer, Oncology

Intervention / Treatment
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* Drug: BIO-106
* Drug: Pembrolizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Multiple ascending dose and dose-expansion of BIO-106 administered as a single agent or in combination with pembrolizumab.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single agent BIO-106<br>Escalating doses followed by expansion targeting advanced cancers | Drug: BIO-106<br>* BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)<br>|
| Experimental: Combination BIO-106 plus pembrolizumab<br>Escalating doses followed by expansion targeting advanced cancers | Drug: BIO-106<br>* BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)<br>Drug: Pembrolizumab<br>* Programmed death receptor-1 (PD 1)-blocking antibody<br>* Other names: Keytruda;|

What is the study measuring?
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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 |