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Tisotumab Vedotin

Tisotumab vedotin is an investigational antibody-drug conjugate being studied in clinical trials for the treatment of various solid tumors. This article summarizes key information from multiple clinical trials evaluating tisotumab vedotin’s safety, efficacy, and pharmacokinetics in patients with advanced cancers like cervical, ovarian, and lung cancer. The trials are exploring tisotumab vedotin both as a monotherapy and in combination with other cancer drugs to determine optimal dosing and identify which patients may benefit most from this targeted therapy approach.

Table of Contents

What is Tisotumab Vedotin?

Tisotumab Vedotin, also known by its brand name TIVDAK, is a new type of cancer drug called an antibody-drug conjugate (ADC)[1]. This means it combines a targeted antibody with a powerful anti-cancer toxin. The drug is designed to specifically seek out and destroy cancer cells while minimizing damage to healthy cells[2].

How Does It Work?

Tisotumab Vedotin works by targeting a protein called tissue factor (TF), which is found in high amounts on many types of cancer cells[2]. The antibody part of the drug attaches to this protein, and then the drug releases its toxic payload (called MMAE) inside the cancer cell, causing it to die[1]. This targeted approach aims to be more effective and potentially less harmful than traditional chemotherapy, which can affect both healthy and cancerous cells.

What Cancers Does It Treat?

Tisotumab Vedotin is being studied for several types of advanced solid tumors, including:

  • Cervical cancer: This is the main focus of many clinical trials, especially for patients whose cancer has returned or spread after previous treatments[2].
  • Ovarian cancer: Studies are looking at its effectiveness in patients with recurrent or advanced ovarian cancer[3].
  • Endometrial cancer: This is cancer of the lining of the uterus[4].
  • Bladder cancer[1]
  • Prostate cancer: Particularly for castrate-resistant prostate cancer (CRPC), which no longer responds to hormone therapy[1].
  • Esophageal cancer[1]
  • Non-small cell lung cancer (NSCLC)[1]
  • Head and neck squamous cell carcinoma (HNSCC)[1]

Clinical Trials and Effectiveness

Several clinical trials have shown promising results for Tisotumab Vedotin, especially in cervical cancer. In one study, about 24% of patients with advanced cervical cancer who had previously received other treatments saw their tumors shrink significantly[2]. This response lasted for an average of about 8.3 months.

For other cancer types, research is still ongoing to determine how effective the drug is. Some trials are comparing Tisotumab Vedotin to standard chemotherapy treatments to see if it works better or has fewer side effects[5].

How Is It Administered?

Tisotumab Vedotin is given as an intravenous (IV) infusion, which means it’s delivered directly into your bloodstream through a vein. The most common dosing schedule is:

  • 2.0 mg/kg (milligrams per kilogram of body weight) every 3 weeks[5]
  • Some trials are also testing different schedules, such as weekly treatments or different doses[3]

Treatment usually continues until the cancer progresses or the side effects become too severe.

Side Effects

Like all cancer treatments, Tisotumab Vedotin can cause side effects. Some of the most common include:

  • Eye problems: This is a significant concern, and patients often need to follow a special eye care plan[6].
  • Fatigue: Feeling very tired is common[1].
  • Nausea and vomiting[1]
  • Bleeding: Some patients may experience nosebleeds or other bleeding issues[4].
  • Peripheral neuropathy: This can cause numbness, tingling, or pain in the hands and feet[4].
  • Skin rash[4]

Your healthcare team will monitor you closely for these and other side effects during treatment.

Ongoing Research

Researchers are continuing to study Tisotumab Vedotin to learn more about its effectiveness and safety. Current areas of investigation include:

  • Combining Tisotumab Vedotin with other cancer treatments like immunotherapy (e.g., pembrolizumab) or chemotherapy (e.g., carboplatin)[7].
  • Testing different dosing schedules to find the most effective and tolerable regimen[3].
  • Studying its effects in different populations, such as Japanese patients with solid tumors[8].
  • Comparing Tisotumab Vedotin directly to standard chemotherapy treatments in large clinical trials[5].

These ongoing studies will help doctors better understand how to use Tisotumab Vedotin and which patients are most likely to benefit from it.

Aspect Details
Drug Name Tisotumab Vedotin (also known as HuMax-TF-ADC, TIVDAK)
Drug Type Antibody-drug conjugate targeting tissue factor
Cancers Studied Cervical, ovarian, endometrial, lung, head and neck, colorectal, pancreatic, prostate, bladder, esophageal
Administration Intravenous infusion
Dosing Schedules Every 3 weeks, weekly for 3 weeks with 1 week off, or other regimens
Primary Outcomes Safety, tolerability, maximum tolerated dose, recommended Phase 2 dose, objective response rate
Secondary Outcomes Pharmacokinetics, duration of response, progression-free survival, overall survival, disease control rate
Common Side Effects Fatigue, nausea, peripheral neuropathy, eye problems, bleeding events, skin rash
Combination Therapies Being studied with pembrolizumab, carboplatin, cisplatin, bevacizumab
Trial Phases Phase 1, Phase 1b/2, Phase 2

FAQ

  • What is tisotumab vedotin? Tisotumab vedotin is an antibody-drug conjugate that targets tissue factor, a protein expressed in many solid tumors. It consists of a monoclonal antibody linked to a cell-killing agent called monomethyl auristatin E (MMAE). The antibody helps deliver the MMAE specifically to cancer cells expressing tissue factor.
  • What types of cancer is tisotumab vedotin being studied for? Clinical trials are evaluating tisotumab vedotin for several types of solid tumors, including cervical cancer, ovarian cancer, endometrial cancer, lung cancer, head and neck cancer, colorectal cancer, pancreatic cancer, and prostate cancer.
  • How is tisotumab vedotin administered? Tisotumab vedotin is given as an intravenous (IV) infusion. The dosing schedules vary between trials, but common regimens include once every 3 weeks or weekly for 3 weeks followed by 1 week off in 28-day cycles.
  • What are the main side effects of tisotumab vedotin? Common side effects observed in clinical trials include fatigue, nausea, peripheral neuropathy, eye problems, bleeding events, and skin rash. Serious adverse events and dose-limiting toxicities are being closely monitored to determine the optimal dose.
  • How effective has tisotumab vedotin been in clinical trials so far? Early clinical trial results have shown promising anti-tumor activity in some patients with advanced solid tumors, particularly in cervical cancer. Objective response rates and duration of response are being evaluated across multiple tumor types. However, more research is needed to fully determine its efficacy.

Ongoing Clinical Trials on Tisotumab Vedotin

  • Sacituzumab Tirumotecan in Recurrent or Metastatic Cervical Cancer After Platinum Chemotherapy and Anti-PD-L1 or Anti-PD-1 Therapy

    Recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Denmark Finland France +9

  • Study of Tisotumab Vedotin, Pembrolizumab, and Platinum Drug Combination for Patients with Advanced or Metastatic Solid Tumors

    Not recruiting

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

  • Study on Tisotumab Vedotin, Bevacizumab, Carboplatin, and Pembrolizumab for Patients with Recurrent or Stage IVB Cervical Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Ireland Italy The Netherlands Spain

  • Study Comparing Tisotumab Vedotin with Chemotherapy for Patients with Recurrent or Metastatic Cervical Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Finland France Germany +7

Glossary

  • Antibody-drug conjugate (ADC): A type of targeted cancer therapy that combines a monoclonal antibody with a potent cell-killing agent. The antibody helps deliver the drug specifically to cancer cells.
  • Tissue factor: A protein that is abnormally expressed in many types of solid tumors and is the target of tisotumab vedotin.
  • Monomethyl auristatin E (MMAE): The cell-killing agent attached to the antibody in tisotumab vedotin. It disrupts cell division and causes cell death.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment. It includes complete responses and partial responses.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives without the cancer progressing or getting worse.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Dose-limiting toxicity (DLT): Side effects that are severe enough to prevent further dose increases of a drug in a clinical trial.
  • Maximum tolerated dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Recommended Phase 2 dose (RP2D): The dose of a drug determined to be suitable for further testing in Phase 2 clinical trials based on safety and efficacy data from Phase 1 trials.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors – a standardized set of rules used to assess tumor response to treatment in cancer clinical trials.

References

  1. https://clinicaltrials.gov/study/NCT02001623
  2. https://clinicaltrials.gov/study/NCT03438396
  3. https://clinicaltrials.gov/study/NCT03657043
  4. https://clinicaltrials.gov/study/NCT02552121
  5. https://clinicaltrials.gov/study/NCT04697628
  6. https://clinicaltrials.gov/study/NCT05866354
  7. https://clinicaltrials.eu/trial/study-on-tisotumab-vedotin-bevacizumab-carboplatin-and-pembrolizumab-for-patients-with-recurrent-or-stage-ivb-cervical-cancer/
  8. https://clinicaltrials.gov/study/NCT03913741