Study of DF1001 in Patients with Advanced Solid Tumors

Sponsor: Dragonfly Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04143711

Provider View

This clinical trial is testing a new treatment called DF1001, which aims to activate the body's natural killer cells and T-cells to target cancer cells. The study will be conducted in two phases, focusing on patients with advanced solid tumors that express the HER2 protein.

Patient Parameters

Program Overview

The study is exploring a new treatment, DF1001, which targets specific receptors on cancer cells to activate the body's immune response. It will be conducted in two phases. The first phase will determine the best dose by testing it on patients with various types of solid tumors that have the HER2 protein. The second phase will expand on this by using the best dose found in the first phase. Patients with specific types of cancer, such as HER2 activated non-small cell lung cancer, hormone receptor positive HER2 negative metastatic breast cancer, or HER2 positive metastatic breast cancer, will be included. DF1001 will be given alone or in combination with other drugs like nivolumab, Nab paclitaxel, and sacituzumab govitecan-hziy.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and have signed a consent form.
  • Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 3 months.
  • Have adequate heart, blood, liver, and kidney function.
  • Women of childbearing potential must use effective contraception.

For specific cancer types:

  • Non-small cell lung cancer (HER2 activated):

    • Cancer has progressed after previous treatments or cannot be removed by surgery.
    • Must have HER2 overexpression or mutation.
    • Must have received and progressed on anti-PD-(L)1 therapy.

  • Metastatic breast cancer (HR+/HER2-):

    • Must have HR+ and HER2- status.
    • Cancer has progressed after previous treatments.

  • Metastatic breast cancer (HER2+):

    • Must have HER2+ status and have received prior treatments like trastuzumab.
    • Cancer has progressed after previous treatments.

  • Dose escalation:

    • Have advanced solid tumors with no standard therapy available.
    • Must have HER2 expression or mutation.

  • Nivolumab combination:

    • Eligible for nivolumab or have no standard therapy available.
    • Must have HER2 expression or mutation.

  • Nab paclitaxel combination:

    • Eligible for nab-paclitaxel or have no standard therapy available.
    • Must have HER2 expression or mutation.

  • Safety/PK/PD expansion:

    • Must provide a fresh tumor biopsy.
    • Must have measurable disease.

  • Urothelial bladder cancer:

    • Must have measurable disease and have received prior treatments.

  • Breast cancer (HER2 low):

    • Must have measurable disease and HER2 low status.
    • Cancer has progressed after one line of chemotherapy.

  • Breast cancer (HER2 high):

    • Must have measurable disease and HER2 high status.

  • Basket erbb2 amplified:

    • Must have measurable disease and erbb2 amplification.
    • Must have received at least one line of therapy.

  • Gastric cancer (HER2 high/low):

    • Must have measurable disease and HER2 status.

  • Esophageal cancer (HER2 high/low):

    • Must have measurable disease and HER2 status.

  • Non-small cell lung cancer (HER2 low/high):

    • Must have measurable disease and HER2 status.
    • Cancer has progressed after chemotherapy.

Exclusion Criteria

  • Currently receiving other cancer treatments or investigational drugs.
  • Have had another cancer within the last 3 years, except for certain skin or cervical cancers.
  • Have rapidly progressing disease or active brain metastases.
  • Have received organ transplants.
  • Have significant infections or autoimmune diseases needing treatment.
  • Have severe allergies or asthma.
  • Have unresolved side effects from previous treatments.
  • Are pregnant or breastfeeding.
  • Have substance abuse issues.
  • Have serious heart conditions or uncontrolled high blood pressure.
  • Have severe breathing difficulties.
  • Have other significant diseases or psychiatric conditions that may affect participation.
  • Are unable to give informed consent.

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