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Clinical Trial 19580

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT03425279

Phase: Phase I/II
Principal Investigator: Druta, Mihaela

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Study Title

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 in Patients with Advanced Solid Tumors


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


Phase 1 (Dose-Escalation Phase) Objectives: Primary: To define the safety profile, including dose limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), of BA3011 administered every 21 days in patients with advanced solid tumors. Ssecondary: To assess the safety of BA3011. To assess the pharmacokinetics (PK) of BA3011 in patients with advanced solid tumors. To evaluate the immunogenicity of BA3011. Phase 2 (Dose-Expansion Phase) Objectives: Primary: To assess antitumor activity of BA3011 in patients with specified tumor types. To assess the safety of BA3011. Secondary: To assess the PK of BA3011 in patients with advanced solid tumors. To evaluate the immunogenicity of BA3011. Exploratory: To explore the relationship between tumor AXL status and clinical response to BA3011 in patients with specified tumors. To evaluate potential candidate tumor and blood-based biomarkers for patient selection or correlation with antitumor activity of BA3011.





BA3011 (); BMS-936558 (Nivolumab); Nivolumab (Opdivo)

Inclusion Criteria

Inclusion Criteria:

  • For the dose escalation phase: Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumor and have failed 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.
  • Participants must have measurable disease.
  • For the dose expansion phase: Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), Stage III or metastatic cutaneous melanoma not amenable to local therapy. Patient may not have a diagnosis of uveal or ocular melanoma. Patients with BRAF V600E/K mutations must have been previously treated with BRAF/MEK inhibitors. Patients who are either ineligible for, intolerant to, or declined BRAF/MEK inhibitor therapy are also eligible for participation.
  • 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

    Exclusion Criteria:

  • Clinically significant cardiac disease in the judgment of the investigator.
  • Known non-controlled CNS metastasis.
  • Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 2 weeks prior to first BA3011 administration.
  • Have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
  • Have Grade 2 or higher peripheral neuropathy.
  • Known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
  • Women who are pregnant or breast feeding.

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