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Disitamab Vedotin

Disitamab Vedotin, also known as RC48-ADC, is an antibody-drug conjugate being studied in clinical trials for various types of cancer that express HER2 (human epidermal growth factor receptor 2). This article summarizes key information about ongoing clinical trials evaluating Disitamab Vedotin’s safety and efficacy in treating different HER2-positive solid tumors, including breast, gastric, colorectal, and other cancers.

Table of Contents

What is Disitamab Vedotin?

Disitamab Vedotin, also known as RC48-ADC or RC48, is a novel cancer treatment that belongs to a class of drugs called antibody-drug conjugates (ADCs)[2]. This medication combines two important components:

  • A humanized anti-HER2 antibody: This is a protein that specifically targets cancer cells expressing HER2 (Human Epidermal Growth Factor Receptor 2) on their surface.
  • Monomethyl auristatin E (MMAE): This is a potent cancer-killing agent attached to the antibody via a special link[10].

Disitamab Vedotin was developed by Rongchang Biology and is currently being studied in various clinical trials to assess its effectiveness and safety in treating different types of cancers[10].

How Does It Work?

Disitamab Vedotin works through a targeted approach:

  1. The antibody part of the drug seeks out and attaches to HER2 proteins on cancer cells.
  2. Once attached, the drug is absorbed by the cancer cell.
  3. Inside the cell, the link between the antibody and MMAE is broken.
  4. The released MMAE then kills the cancer cell[2].

This targeted method allows the drug to deliver its cancer-killing effects directly to tumor cells while minimizing damage to healthy cells.

What Types of Cancers Does Disitamab Vedotin Treat?

Disitamab Vedotin is being studied for the treatment of various cancers that express HER2. These include:

  • Bladder Cancer: Specifically, high-risk non-muscle-invasive bladder cancer that overexpresses HER2[1].
  • Breast Cancer: Including HER2-low expressing metastatic breast cancer[6][10].
  • Gastric and Gastroesophageal Junction Cancer: Advanced stages that overexpress HER2[3].
  • Colorectal Cancer: Advanced HER2-positive colorectal cancer[9].
  • Pancreatic Cancer: Locally advanced or metastatic pancreatic cancer expressing HER2[5].
  • Other Solid Tumors: Including head and neck squamous cell cancer, non-small cell lung cancer, endometrial cancer, and ovarian cancer that express HER2[2].

Current Clinical Trials

Disitamab Vedotin is currently being evaluated in several clinical trials:

  • A study combining Disitamab Vedotin with Tislelizumab (an immunotherapy drug) for bladder cancer[1].
  • A trial testing Disitamab Vedotin alone or in combination with other drugs for various solid tumors[2].
  • A real-world study of Disitamab Vedotin in patients with advanced gastric cancer and other solid tumors[3].
  • A study combining Disitamab Vedotin with radiotherapy for locally advanced solid tumors[4].
  • Trials for breast cancer, including HER2-low expressing types[6][8].
  • A study for colorectal cancer combining Disitamab Vedotin with Tislelizumab[9].

How is Disitamab Vedotin Administered?

Disitamab Vedotin is typically administered as an intravenous (IV) infusion. The dosage and frequency can vary depending on the specific trial and cancer type, but common regimens include:

  • 2.0 mg/kg every 2 weeks[6]
  • 2.5 mg/kg every 3 weeks[5]

The treatment is often given in cycles, with each cycle lasting 2-3 weeks. The total duration of treatment can vary, but it may continue until the cancer progresses or unacceptable side effects occur[9].

Potential Side Effects

As with any cancer treatment, Disitamab Vedotin may cause side effects. While specific side effects are still being studied in clinical trials, common side effects of antibody-drug conjugates may include:

  • Fatigue
  • Nausea
  • Decreased appetite
  • Hair loss
  • Numbness or tingling in hands and feet

The severity and frequency of side effects are being closely monitored in ongoing clinical trials[3].

Future Prospects

Disitamab Vedotin shows promise in treating various HER2-expressing cancers, particularly in cases where current treatments have failed. Ongoing research is exploring its potential in different cancer types and in combination with other therapies[8][9].

As clinical trials progress, more information about the effectiveness and safety of Disitamab Vedotin will become available, potentially leading to new treatment options for patients with HER2-expressing cancers.

Aspect Details
Drug Name Disitamab Vedotin (RC48-ADC)
Target HER2-expressing cancers
Cancer Types Studied Breast, gastric, colorectal, pancreatic, and other solid tumors
Administration Intravenous infusion, typically every 2-3 weeks
Key Outcomes Measured Progression-free survival, overall survival, objective response rate, safety
Combination Therapies Being studied alone and in combination with other drugs (e.g., tislelizumab, toripalimab)
Trial Phases Phase 1 and 2 studies ongoing

FAQ

  • What is Disitamab Vedotin? Disitamab Vedotin is an antibody-drug conjugate designed to target and kill cancer cells that express HER2. It combines an anti-HER2 antibody with a potent chemotherapy drug to deliver treatment directly to cancer cells.
  • What types of cancer is Disitamab Vedotin being studied for? Clinical trials are evaluating Disitamab Vedotin for various HER2-expressing cancers, including breast cancer, gastric cancer, colorectal cancer, pancreatic cancer, and other solid tumors.
  • How is Disitamab Vedotin administered? Disitamab Vedotin is typically given as an intravenous (IV) infusion every 2 or 3 weeks. The exact dosage and schedule may vary between trials.
  • What are some potential side effects of Disitamab Vedotin? While specific side effects can vary, clinical trials are monitoring for adverse events such as fatigue, nausea, decreased blood cell counts, and potential effects on heart function. The safety profile is being carefully evaluated in each study.
  • How can I find out if I'm eligible for a clinical trial with Disitamab Vedotin? Eligibility criteria vary between trials but often include having a HER2-expressing cancer that has progressed after standard treatments. Speak with your oncologist about whether you might be a candidate for a clinical trial involving Disitamab Vedotin.

Ongoing Clinical Trials on Disitamab Vedotin

  • A Study of Disitamab Vedotin for Adults with HER2 Expressing Advanced Breast Cancer

    Recruiting

    1 1
    Investigated drugs:
    Germany Italy Spain

  • Study of Disitamab Vedotin and Tucatinib for Patients with Advanced Breast Cancer or Gastric Cancer

    Recruiting

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

  • Study of Disitamab Vedotin alone or with Pembrolizumab in patients with locally advanced or metastatic urothelial cancer that expresses HER2

    Not yet recruiting

    1 1
    Investigated drugs:
    Belgium France Italy Spain

  • Study of Disitamab Vedotin for Adults with Previously Treated HER2-Positive Solid Tumors, Including Lung, Head and Neck, Ovarian, and Endometrial Cancers

    Not yet recruiting

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

  • Study of Disitamab Vedotin and Pembrolizumab for Patients with Advanced or Metastatic Urothelial Cancer Expressing HER2

    Not yet recruiting

    1 1 1
    Investigated drugs:
    Belgium Hungary Italy Spain

  • Study of Disitamab Vedotin and Pembrolizumab for Patients with Untreated Advanced Urothelial Cancer Expressing HER2

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium Czechia France Greece Hungary +7

Glossary

  • HER2: Human Epidermal Growth Factor Receptor 2, a protein that promotes the growth of cancer cells. Some cancers have higher than normal levels of HER2.
  • Antibody-drug conjugate (ADC): A type of targeted cancer therapy that combines a monoclonal antibody with a potent chemotherapy drug to deliver treatment directly to cancer cells.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • 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.
  • Disease control rate (DCR): The percentage of patients who achieve complete response, partial response, or stable disease with treatment.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment.
  • Immunohistochemistry (IHC): A lab test that uses antibodies to detect certain proteins in a tissue sample. Used to determine HER2 status in cancer cells.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.

References

  1. https://clinicaltrials.gov/study/NCT05495724
  2. https://clinicaltrials.eu/trial/study-of-disitamab-vedotin-for-adults-with-previously-treated-her2-positive-solid-tumors-including-lung-head-and-neck-ovarian-and-endometrial-cancers/
  3. https://clinicaltrials.gov/study/NCT05649163
  4. https://clinicaltrials.gov/study/NCT05940896
  5. https://clinicaltrials.gov/study/NCT06233864
  6. https://clinicaltrials.gov/study/NCT05831878
  7. https://clinicaltrials.gov/study/NCT05851677
  8. https://clinicaltrials.gov/study/NCT06105008
  9. https://clinicaltrials.gov/study/NCT05493683
  10. https://clinicaltrials.gov/study/NCT06000033