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Df6002

A groundbreaking clinical trial is underway to investigate the potential of DF6002, a new drug being studied for the treatment of advanced solid tumors. This trial aims to evaluate the safety, effectiveness, and biological impact of DF6002 when used alone or in combination with Nivolumab, a known cancer immunotherapy drug. The study focuses on patients with locally advanced or metastatic solid tumors, offering hope for those with limited treatment options.

Table of Contents

What is DF6002?

DF6002 is a new investigational drug that is currently being studied for its potential in treating advanced solid tumors[1]. It is undergoing clinical trials to determine its safety, how it behaves in the body (pharmacokinetics), and its effectiveness against cancer. This drug is still in the early stages of research, specifically in a Phase 1/2 clinical trial, which means it’s being tested in humans for the first time.

What conditions does DF6002 target?

The primary focus of the current study is on patients with locally advanced or metastatic solid tumors[1]. Solid tumors are abnormal masses of tissue that don’t contain cysts or liquid areas. They may occur in various parts of the body. The term “locally advanced” means the cancer has spread from where it started to nearby tissue or lymph nodes. “Metastatic” refers to cancer that has spread to other parts of the body.

The study is particularly interested in two types of cancer:

  • Melanoma: A type of skin cancer that develops in cells called melanocytes, which produce melanin (the pigment that gives skin its color).
  • Non-Small Cell Lung Cancer (NSCLC): The most common type of lung cancer, accounting for about 80-85% of all cases.

Current Clinical Trial

The ongoing clinical trial for DF6002 is titled “A Study of DF6002 Alone and in Combination With Nivolumab”[1]. This study aims to investigate several aspects of DF6002:

  • Safety: How safe is the drug for human use?
  • Tolerability: How well can patients tolerate the drug without severe side effects?
  • Pharmacokinetics: How does the body process the drug?
  • Biological effects: What changes does the drug cause in the body?
  • Clinical activity: How effective is the drug against cancer?

Study Design

The study is designed as a Phase 1/2, first-in-human, multi-part, open-label, multiple-ascending dose study[1]. Let’s break down what this means:

  • Phase 1/2: This combines the initial safety testing (Phase 1) with early efficacy testing (Phase 2).
  • First-in-human: This is the first time the drug is being tested in people.
  • Multi-part: The study has several different components or stages.
  • Open-label: Both the researchers and the participants know which treatment is being given.
  • Multiple-ascending dose: The study will test different doses of the drug, typically starting low and increasing to find the best dose.

The study is divided into several arms or groups[1]:

  1. Monotherapy Dose Escalation: Testing different doses of DF6002 alone.
  2. Monotherapy Dose Expansion (Melanoma): Further testing of DF6002 alone in melanoma patients.
  3. Monotherapy Dose Expansion (NSCLC): Further testing of DF6002 alone in NSCLC patients.
  4. Combination Dose Escalation: Testing different doses of DF6002 combined with Nivolumab.
  5. Combination Dose Expansion (Melanoma): Further testing of DF6002 with Nivolumab in melanoma patients.
  6. Combination Dose Expansion (NSCLC): Further testing of DF6002 with Nivolumab in NSCLC patients.

Safety Evaluation

A crucial aspect of this study is evaluating the safety of DF6002. The researchers will be closely monitoring several factors[1]:

  • Dose-limiting toxicities (DLTs): These are side effects severe enough to prevent an increase in dosage. They will be monitored during the first 3 weeks of treatment.
  • Treatment emergent adverse events (TEAEs): Any unfavorable and unintended sign, symptom, or disease that appears or worsens after starting the treatment.
  • Changes in laboratory test results, electrocardiogram (ECG) readings, vital signs, and overall patient performance status.

Efficacy Measures

To determine how well DF6002 works against cancer, the study will look at several measures[1]:

  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Duration of Response (DOR): How long the cancer remains controlled after it has responded to treatment.
  • Best Overall Response (BOR): The best response to treatment that a patient achieves over the course of the study.
  • Clinical Benefit Rate (CBR): The percentage of patients who have achieved complete response, partial response, or stable disease.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it worsening.
  • Overall Survival (OS): How long patients survive after starting treatment.

Combination Therapy with Nivolumab

Part of this study is investigating DF6002 in combination with another drug called Nivolumab (also known as Opdivo)[1]. Nivolumab is an immunotherapy drug already approved for treating several types of cancer, including melanoma and NSCLC. The researchers want to see if combining DF6002 with Nivolumab might be more effective than using either drug alone.

Important Considerations for Patients

If you’re considering participating in this or any clinical trial, here are some important points to keep in mind:

  • This is an early-phase study, which means the drug is still being tested for safety and the right dosage.
  • The study involves multiple visits and tests to closely monitor your health and the drug’s effects.
  • You may experience side effects, some of which could be severe or unexpected.
  • There’s no guarantee that the treatment will be effective for your cancer.
  • Participation in the study may affect your ability to participate in other treatment options or clinical trials.

Always discuss with your healthcare provider to understand if participating in a clinical trial is right for you.

Aspect Details
Study Drug DF6002
Combination Drug Nivolumab (Opdivo)
Target Condition Advanced solid tumors (including melanoma and non-melanoma skin cancers)
Administration Subcutaneous or Intravenous, every 4 weeks
Study Type Phase 1/1b, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose
Primary Outcomes Number of participants with dose-limiting toxicities, Overall Response Rate
Secondary Outcomes Safety profile, Pharmacokinetics, Duration of Response, Progression-Free Survival, Overall Survival
Study Arms Monotherapy and Combination therapy, Dose Escalation, Safety/PK/PD, Efficacy Expansion

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the safety, tolerability, drug levels, drug effects, and preliminary anti-tumor activity of DF6002 when used alone and in combination with Nivolumab in patients with advanced solid tumors.
  • How is DF6002 administered in this trial? DF6002 is administered either subcutaneously (under the skin) or intravenously (into a vein) every 4 weeks. The subcutaneous portion of the study has been completed.
  • What types of cancer are being studied in this trial? This trial focuses on patients with advanced solid tumors, including melanoma and non-melanoma skin cancers such as cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), and Merkel cell carcinoma (MCC).
  • What is Nivolumab and how is it used in this study? Nivolumab, also known as Opdivo, is an immunotherapy drug used in cancer treatment. In this study, it is administered every 4 weeks in combination with DF6002 to evaluate their combined effectiveness against solid tumors.
  • What are some of the key outcomes being measured in this trial? The trial measures several outcomes, including the number of participants experiencing dose-limiting toxicities, overall response rate to the treatment, duration of response, progression-free survival, and overall survival. It also assesses safety by monitoring adverse events and changes in various clinical parameters.

Ongoing Clinical Trials on Df6002

  • Study of DF6002 alone and combined with nivolumab in patients with advanced solid tumors: A safety and effectiveness trial

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France Spain

Glossary

  • Solid Tumors: Abnormal masses of tissue that don't contain cysts or liquid areas. Solid tumors may be benign (not cancerous) or malignant (cancerous).
  • Metastatic: Cancer that has spread from the place where it first started to another place in the body.
  • Subcutaneous: Beneath the skin. In this study, it refers to a method of administering medication by injection under the skin.
  • Intravenous (IV): Into or within a vein. Intravenous usually refers to giving medications or fluids through a needle or tube inserted into a vein.
  • Monotherapy: Treatment using a single drug.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug or treatment that does not cause unacceptable side effects.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Pharmacodynamics (PD): The study of the biochemical and physiological effects of drugs on the body.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a decrease in dose.
  • Overall Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • RECIST: Response Evaluation Criteria in Solid Tumors – a standard way to measure how well a cancer patient responds to treatment.
  • Treatment Emergent Adverse Events (TEAEs): Any unfavorable and unintended sign, symptom, or disease that appears or worsens during a clinical study after a patient has started receiving their treatment.
  • Duration of Response (DOR): The length of time that a tumor continues to respond to treatment without the cancer growing or spreading.
  • Progression-Free Survival (PFS): The length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
  • Overall Survival (OS): The length of time from either the date of diagnosis or the start of treatment for a disease that patients diagnosed with the disease are still alive.

References