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Study on DF1001, Nivolumab, and Paclitaxel for Patients with Advanced Solid Tumors

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment called DF1001 in patients with advanced solid tumors. Solid tumors are abnormal masses of tissue that can occur in various parts of the body and may be difficult to remove or treat. The study aims to understand how safe and tolerable DF1001 is when used alone or in combination with other treatments, such as nivolumab and nab-paclitaxel. Nivolumab is a medication that helps the immune system fight cancer, while nab-paclitaxel is a form of chemotherapy that targets cancer cells. The study will also explore the effects of combining DF1001 with another drug called sacituzumab govitecan.

The purpose of this study is to find the most effective and safe dose of DF1001 for treating these tumors. Participants will receive the treatment through an infusion, which means the medication is given directly into the bloodstream. The study will be conducted in several parts, starting with a dose escalation phase to determine the safest dose, followed by an exploratory phase to assess the treatment's effectiveness. The final phase will expand the study to include more patients to confirm the results.

Throughout the study, researchers will monitor participants closely to observe any side effects and measure how well the tumors respond to the treatment. The goal is to gather information that could lead to new treatment options for patients with advanced solid tumors. This study is an important step in understanding how DF1001 and its combinations can potentially improve outcomes for patients with these challenging conditions.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient provides a signed written informed consent.

    Eligibility is confirmed based on criteria such as age (18 years or older), performance status, and adequate organ function.

  2. Step 2

    Initial assessment

    The patient undergoes a baseline assessment, which includes measuring the disease using specific criteria and evaluating heart function through echocardiography or a MUGA scan.

  3. Step 3

    Dose escalation phase

    The patient receives DF1001 as a monotherapy or in combination with nivolumab or nab-paclitaxel through intravenous infusion.

    The goal is to determine the maximum tolerated dose and assess safety and tolerability over the first 21 days.

  4. Step 4

    Exploratory efficacy phase

    The patient may receive DF1001 alone or with sacituzumab govitecan to evaluate the response rate and further assess safety.

    Regular monitoring of adverse events and treatment effects is conducted.

  5. Step 5

    Efficacy expansion phase

    The patient continues treatment to confirm the response rate according to specific evaluation criteria.

    Ongoing assessments include physical exams, vital signs, and laboratory tests.

  6. Step 6

    Completion of treatment

    The study is estimated to conclude by October 2026, with follow-up assessments to monitor long-term outcomes and any late-emerging effects.

Who can join the trial?

9 criteria

  • You must sign a written informed consent form, which means you agree to participate in the study after being informed about it.
  • You must be a male or female aged 18 years or older.
  • You need to have an ECOG performance status of 0 to 1. This is a scale that measures your ability to perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Your disease must be measurable with at least one measurable lesion, which is a specific area of the tumor that can be measured to track changes.
  • Your baseline LVEF (Left Ventricular Ejection Fraction) must be 55% or higher. This is a measure of how well your heart is pumping blood.
  • You must have adequate blood cell counts, which means having enough white blood cells, neutrophils, lymphocytes, and platelets, as well as a stable hemoglobin level.
  • Your liver function must be adequate, meaning your bilirubin level should be 1.5 times the normal limit or lower, and your AST and ALT levels should be 2.5 times the normal limit or lower, unless you have liver disease, in which case they can be up to 5 times the normal limit.
  • Your kidney function must be adequate, with a creatinine clearance of 50 mL/min or higher. This measures how well your kidneys are filtering waste from your blood.
  • If you are of childbearing potential, you must agree to use effective contraception methods during the study and for a specified period after the last dose. Men must use condoms during treatment and for a period after the last dose.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the ones being studied.
  • Patients who have not recovered from previous treatments or surgeries.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had an allergic reaction to similar treatments in the past.
  • Patients who are unable to follow the study procedures or attend required visits.
  • Patients who have a history of substance abuse that could affect their participation.
  • Patients who have certain infections that are not well controlled.
  • Patients who have received certain medications recently that could interfere with the study.
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Investigated drugs

  • DF1001

    is an experimental medication being tested for its safety and effectiveness in treating patients with advanced solid tumors. The study aims to find the highest dose of DF1001 that patients can tolerate without severe side effects. It is being tested both as a standalone treatment and in combination with other medications.

  • Nivolumab

    is a medication that helps the immune system recognize and attack cancer cells. In this trial, it is used in combination with DF1001 to see if the two medications together can improve treatment outcomes for patients with advanced solid tumors.

  • Nab-paclitaxel

    is a chemotherapy drug that works by stopping cancer cells from dividing and growing. It is being combined with DF1001 in this study to evaluate if the combination is more effective than DF1001 alone in treating advanced solid tumors.

  • Sacituzumab govitecan-hziy

    is a targeted therapy that delivers chemotherapy directly to cancer cells. In this trial, it is combined with DF1001 to explore if this combination can enhance the treatment's effectiveness against advanced solid tumors.

What is already known about the treatment

DF1001 – This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating locally advanced or metastatic solid tumors. It is in the early stages of research, specifically in Phase I/II trials, and is not yet widely used in standard medical practice. DF1001 is being investigated for its potential to treat various solid tumors, either alone or in combination with other drugs like nivolumab and nab-paclitaxel. At the molecular level, DF1001 works by targeting specific proteins on cancer cells, aiming to enhance the immune system's ability to recognize and destroy these cells. It is classified as an investigational immunotherapy agent.

Investigated diseases

Locally Advanced or Metastatic Solid Tumors – These are cancers that have spread beyond their original site to nearby tissues or distant parts of the body. They are characterized by the growth of abnormal cells that form a mass or lump, which can invade surrounding tissues. As the disease progresses, it can spread to other organs through the bloodstream or lymphatic system. The symptoms and progression depend on the type of tumor and the organs affected. These tumors can cause pain, swelling, and other symptoms related to the affected area. The progression can vary widely, with some tumors growing slowly and others spreading rapidly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503291-24-00Protocol codeDF1001-001Estimated enrolment388 patientsSponsorDragonfly Therapeutics Inc.

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