#1 Clinical Trials Search in Europe

Db-1303

DB-1303/BNT323 is an investigational drug currently being studied in clinical trials for the treatment of advanced breast cancer and endometrial cancer. These trials aim to compare the efficacy and safety of DB-1303/BNT323 with existing treatments in patients who have already undergone previous therapies. The studies focus on specific patient populations, including those with HER2-positive breast cancer, HER2-low hormone receptor-positive breast cancer, and recurrent endometrial cancer.

Table of Contents

What is DB-1303?

DB-1303, also known as BNT323, is a new investigational drug being studied for the treatment of certain types of cancer[1][2][3]. It belongs to a class of medications called antibody-drug conjugates (ADCs). This means DB-1303 combines a targeted antibody (a type of protein that can recognize specific cancer cells) with a powerful anti-cancer drug. This combination allows the medication to deliver the cancer-fighting drug directly to the tumor cells while minimizing damage to healthy cells.

What Conditions Does DB-1303 Treat?

DB-1303 is currently being studied for the treatment of several types of cancer:

  • HER2-positive breast cancer: This is a type of breast cancer where the cancer cells have too much of a protein called HER2 on their surface, which helps the cancer grow and spread quickly[1].
  • HER2-low, hormone receptor-positive (HR+) metastatic breast cancer: This is a type of breast cancer that has spread to other parts of the body, with lower levels of HER2 protein and positive hormone receptors[2].
  • Endometrial cancer: This is a cancer that starts in the lining of the uterus (womb)[3].

How Does DB-1303 Work?

DB-1303 works by targeting cancer cells that have the HER2 protein on their surface. The antibody part of DB-1303 attaches to the HER2 protein, and then the drug part is released into the cancer cell to kill it. This targeted approach may help to reduce side effects compared to traditional chemotherapy, which can affect both healthy and cancerous cells[1][2].

Current Clinical Trials

DB-1303 is currently being studied in several large clinical trials:

  1. DYNASTY-Breast01: This study is comparing DB-1303 to a drug called T-DM1 in patients with HER2-positive breast cancer that has spread or cannot be surgically removed[1].
  2. DYNASTY-Breast02: This trial is comparing DB-1303 to standard chemotherapy in patients with HER2-low, HR+ metastatic breast cancer[2].
  3. Endometrial Cancer Study: This study is comparing DB-1303 to standard chemotherapy in patients with recurring endometrial cancer[3].

How is DB-1303 Administered?

DB-1303 is given as an intravenous (IV) infusion, which means it’s delivered directly into the bloodstream through a vein. The exact dosing schedule may vary depending on the specific clinical trial, but it’s typically given once every three weeks[1][2][3].

Potential Effectiveness of DB-1303

The effectiveness of DB-1303 is still being studied, but researchers are looking at several important measures:

  • Progression-free survival (PFS): This measures how long patients live without their cancer getting worse[1][2][3].
  • Overall survival (OS): This measures how long patients live overall[1][2][3].
  • Objective response rate (ORR): This measures the percentage of patients whose tumors shrink or disappear after treatment[1][2][3].
  • Duration of response (DoR): This measures how long the cancer remains controlled after it responds to treatment[1][2][3].

Possible Side Effects

As with all medications, DB-1303 may cause side effects. The full range of potential side effects is still being studied, but researchers are carefully monitoring for:

  • Serious adverse events (SAEs)
  • Treatment-emergent adverse events (TEAEs)
  • Side effects that may lead to stopping or changing the treatment

These side effects are being compared to those of standard chemotherapy treatments to determine if DB-1303 offers any advantages in terms of safety[1][2][3].

Impact on Patient Quality of Life

An important aspect of the DB-1303 clinical trials is assessing how the treatment affects patients’ overall quality of life. This is being measured using several questionnaires:

  • EORTC QLQ-C30: This measures general cancer-related quality of life[1][2].
  • EORTC QLQ-BR45: This is specific to breast cancer symptoms and concerns[1][2].
  • EQ-5D-5L: This measures overall health status[1][2].

These assessments help researchers understand how DB-1303 affects patients’ daily lives and overall well-being compared to other treatments.

Aspect Details
Drug Name DB-1303/BNT323
Administration Intravenous (IV) infusion
Cancer Types HER2-positive breast cancer, HER2-low hormone receptor-positive breast cancer, Recurrent endometrial cancer
Trial Phase Phase III
Comparators T-DM1, Investigator’s choice of chemotherapy (e.g., doxorubicin, paclitaxel, capecitabine)
Primary Outcomes Progression-Free Survival (PFS)
Secondary Outcomes Overall Survival (OS), Objective Response Rate (ORR), Duration of Response (DoR), Safety and tolerability
Patient-Reported Outcomes Quality of life measures using EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L
Trial Duration Up to approximately 24-52 months

FAQ

  • What is DB-1303/BNT323? DB-1303/BNT323 is an investigational drug being studied for the treatment of advanced breast cancer and endometrial cancer. It is administered intravenously (through a vein) and is being compared to other established treatments in clinical trials.
  • What types of cancer is DB-1303/BNT323 being tested for? DB-1303/BNT323 is being tested in clinical trials for HER2-positive breast cancer, HER2-low hormone receptor-positive breast cancer, and recurrent endometrial cancer.
  • How is DB-1303/BNT323 given to patients? DB-1303/BNT323 is administered to patients through intravenous (IV) infusion, which means it is given directly into a vein.
  • What are the main goals of these clinical trials? The main goals of these trials are to assess the efficacy and safety of DB-1303/BNT323 compared to current standard treatments. They measure outcomes such as progression-free survival, overall survival, and objective response rate.
  • How long do these clinical trials last? The duration of these clinical trials varies, but they generally last up to 24-52 months. During this time, researchers monitor patients' responses to the treatment and any side effects that may occur.

Ongoing Clinical Trials on Db-1303

  • A Study of BNT323 and BNT327 for Patients with Advanced Breast Cancer to Test Safety and Effectiveness

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • A study comparing BNT323 with chemotherapy in patients with HER2-expressing recurrent endometrial cancer who received previous treatment

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +9

  • Study Comparing DB-1303 and Chemotherapy for Patients with HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Belgium France Germany Hungary Italy Poland +1

Glossary

  • HER2-positive: A type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • Overall Survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Blinded Independent Central Review (BICR): A method where independent experts review patient data without knowing which treatment the patient received, to ensure unbiased assessment.
  • Endometrial Cancer: A type of cancer that begins in the lining of the uterus (endometrium).
  • Hormone Receptor Positive (HR+): Cancer cells that have receptors for either estrogen or progesterone, which can promote the growth of the cancer.
  • Immunohistochemistry (IHC): A lab test that uses antibodies to check for certain proteins in a sample of tissue, used to determine HER2 status.

References