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Recruiting NCT05320588

A Study in Patients With Advanced Cancers

Phase I / Phase II Interventional Advanced Cancer Advanced Solid Tumor Cancer Oncology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BIO-106, Pembrolizumab.
Who it may be relevant to
Registry conditions: Advanced Cancer, Advanced Solid Tumor, Cancer, Oncology. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) [Time frame: 1 year]
  • Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1) [Time frame: up to 21 days]
  • Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) [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) [Time frame: 2 years]
Secondary outcome measures (6)
  • 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

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • NEXT Oncology Austin — Austin
  • University of Texas MD Anderson Cancer Center — Houston
  • NEXT Oncology Virginia — Fairfax

Identifiers

NCT: NCT05320588 · StarBridge-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗