Clinical Trial 19776

• Overview

  Study Title:

  A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 Alone and in Combination with Nivolumab in Patients with Advanced Solid Tumors

  Summary:

  The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors

  Objective:

  Phase 1 (Dose-Escalation Phase) Objectives Primary: To define the safety profile, including DLT, and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and other safety parameters of BA3021 administered every 21 days in patients with advanced solid tumors. Secondary: To assess the pharmacokinetics (PK) of BA3021 in patients with advanced solid tumors. To evaluate the immunogenicity of BA3021. Phase 2 (Dose-Expansion Phase) Objectives Primary: To assess antitumor activity of BA3021 in patients with specified tumor types. To assess the safety of BA3021. Secondary: To assess the PK of BA3021 in patients with advanced solid tumors. To evaluate the immunogenicity of BA3021. Exploratory: To explore the relationship between tumor ROR2 status and clinical response to BA3021 in patients with specified tumors. To evaluate potential candidate tumor and blood-based biomarkers for patient selection or correlation with antitumor activity of BA3021.

• Treatments

  Therapies:

  Immunotherapy; Therapy (NOS)

  Medications:

  BA3021 (); BMS-936558 (Nivolumab); Nivolumab (Opdivo)

• Inclusion Criteria

  • Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.
  • Patients must have measurable disease.
  • For the dose expansion phase: Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC) and soft tissue sarcoma (STS)
  • Age > 18 years.
  • Adequate renal function
  • Adequate liver function
  • Adequate hematological function
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy of at least three months.

• Exclusion Criteria

  • Patients must not have clinically significant cardiac disease.
  • Patients must not have known non-controlled CNS metastasis.
  • Patients must not have a history of > Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study.
  • Patients must not have had major surgery within 4 weeks before first BA3021 administration.
  • Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
  • Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
  • Patients must not be women who are pregnant or breast feeding.

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