Clinical Trial 23716

• Overview

  Study Title:

  A Phase 1/2, First-in-Human Study To Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors

  Summary:

  This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.

  Objective:

  Primary Objectives: Phase 1 Dose Escalation: - To determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) of AVZO-1418 as monotherapy and in combination therapy - To characterize the safety and tolerability of AVZO-1418 as monotherapy and in combination therapy Phase 2 Dose Expansion: - To assess the antitumor activity of AVZO-1418 as monotherapy and in combination therapy using RECIST v1.1, as assessed by the Investigator Secondary Objectives: Phase 1 Dose Escalation: - To assess preliminary antitumor activity of AVZO-1418, as monotherapy and in combination therapy using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the Investigator - To characterize the PK of AVZO-1418, total antibody, and free payload (P1021) - To assess the immunogenicity of AVZO-1418 Phase 2 Dose Expansion: - To confirm the RP2D of AVZO-1418 in selected tumor types as monotherapy and in combination therapy - To further characterize the antitumor activity of AVZO-1418 as monotherapy and in combination therapy using - To further characterize the safety and tolerability of AVZO-1418 - To further characterize PK of AVZO-1418, total antibody, and free payload when given as monotherapy and in combination therapy - To assess the immunogenicity of AVZO-1418

• Treatments

  Therapies:

  Bispecific antibody-drug conjugate; Immunotherapy; Tyrosine Kinase Inhibitor

  Medications:

  AVZO-1418 (); AZD9291 (Osimertinib); Osimertinib (); Pembrolizumab (Keytruda)

• Inclusion Criteria

  Key Inclusion Criteria
  • Patient must be an adult, between 18 and 75 years of age with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of > 3 months.
  • Patients with histologically or cytologically confirmed locally advanced/metastatic malignancies for tumor types of preferred indications: Locally advanced or metastatic epithelial solid tumors (as specified in the protocol).
  • Measurable disease as assessed by Investigator using RECIST v1.1.
  • Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable.
  • Other protocol-defined Inclusion criteria apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Uncontrolled hypertension.
  • Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.
  • History of drug-induced interstitial lung disease (ILD).
  • History of any serious cardiovascular condition.
  • Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.
  • History of a solid organ transplant.
  • Other protocol-defined Exclusion criteria apply.

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