Clinical Trial 23069

• Overview

  Study Title:

  Phase 1/1b, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 in Patients with Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors

  Summary:

  DF6215-001 is a study of a modified human cytokine (interleukin-2; IL-2) that retains the ability to bind to a certain part of the IL-2 receptor on a subset of white blood cells (lymphocytes), which can help recognize and kill tumor cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors. The second phase, Phase 1b, will include a dose expansion using the best dose selected from the first phase of the study. A cohort will be opened with eligible patients having a select solid tumor.

  Objective:

  Primary: * To determine the maximum tolerated dose (MTD) of DF6215 * To determine clinical activity of DF6215 Secondary: * To assess the safety and tolerability of DF6215 * To assess the pharmacokinetics (PK) of DF6215 * To assess the immunogenicity of DF6215

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  DF6215 ()

• Inclusion Criteria

  Inclusion Criteria All Cohorts:
  • Male or female patients aged 18 years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months
  • Adequate hematological function
  • Adequate cardiac function
  • Effective contraception
  • 3 + 3 Dose Escalation Criteria:
  • Histologically or cytologically proven locally advanced or metastatic solid tumor, for which no standard therapy exists, or standard therapy has failed
  • Evidence of objective disease (but participation does not require a measurable lesion)
  • Archived tumor biopsy. If archival tissue is unavailable, a fresh tumor biopsy is required, obtained within the screening window.
  • Safety/PK/PD Inclusion Criteria:
  • Histologically or cytologically proven locally advanced or metastatic solid tumor from the following list, where standard therapy does not exist or has failed: Melanoma HPV-positive advanced malignancies Ovarian cancer Head and neck cancer Lung cancer (non-small-cell lung cancer [NSCLC]) Renal cell carcinoma (RCC) Other tumor types may be eligible after discussion with the Sponsor medical monitor
  • Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
  • A fresh tumor biopsy must be obtained during the screening window and on-treatment
  • Efficacy Expansion Inclusion Criteria:
  • Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
  • A fresh tumor biopsy must be obtained during the screening window and on-treatment

• Exclusion Criteria

  Exclusion Criteria All Cohorts:
  • Patients receiving chemotherapy, radiotherapy (other than palliative bone-directed radiotherapy), major surgery, or receiving another therapeutic agent within 28 days before the start of study drug or within 5 half-lives of the previous therapeutic agent (if known), whichever is shorter
  • Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [except for palliative bone-directed radiotherapy], immune therapy, or cytokine therapy [except for erythropoietin]), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of treatment or within 5 half-lives of the previous therapeutic agent (if known), whichever is shorter. Short-term administration of systemic steroids (eg, for allergic reactions or the management of immune-related adverse events [irAEs]) is allowed.
  • Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, low-grade prostate cancer (Gleason score ≤ 6 and must be Stage I or II), or cervical carcinoma in situ
  • Life expectancy of less than 3 months
  • Patients with brain metastases are excluded, unless all of the following criteria are met: Central nervous system (CNS) lesions are asymptomatic and previously treated Patient does not require ongoing daily steroid treatment for replacement for adrenal insufficiency (except ≤ 10 mg prednisone [or equivalent]) Imaging demonstrates stable disease 28 days after last treatment
  • Receipt of any organ transplant, including autologous or allogeneic stem-cell transplantation
  • Pregnancy or lactation during the study

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