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Futibatinib

Futibatinib is an investigational drug being studied in clinical trials for the treatment of various advanced cancers. These trials aim to evaluate the safety and effectiveness of futibatinib, either alone or in combination with other therapies, in patients with specific genetic mutations or tumor types. The research focuses on cancers like cholangiocarcinoma, breast cancer, and other solid tumors with FGFR gene alterations.

Table of Contents

What is Futibatinib?

Futibatinib, also known as TAS-120 or Lytgobi, is a promising new drug being studied for the treatment of various types of cancer[1][2]. It belongs to a class of medications called FGFR inhibitors, which target specific proteins involved in cancer growth[3].

How Futibatinib Works

Futibatinib works by blocking proteins called Fibroblast Growth Factor Receptors (FGFRs). These proteins are often overactive in certain types of cancer, causing tumor cells to grow and spread. By inhibiting these receptors, futibatinib may help slow down or stop cancer growth[4].

Cancers Treated with Futibatinib

Futibatinib is being studied for the treatment of several types of cancer, including:

  • Cholangiocarcinoma (bile duct cancer)[1]
  • Urothelial cancer (bladder cancer)[5]
  • Non-small cell lung cancer[6]
  • Hepatocellular carcinoma (liver cancer)[2]
  • Breast cancer[1]
  • Gastric cancer (stomach cancer)[1]
  • Endometrial cancer (cancer of the uterus lining)[7]

The drug is particularly effective in cancers with specific genetic changes in the FGFR genes, such as mutations, fusions, or amplifications[4].

Clinical Trials and Research

Futibatinib is currently being studied in various clinical trials to determine its effectiveness and safety. These trials include:

  • Phase 1/2 studies to determine the best dose and evaluate its effectiveness in different cancer types[1]
  • Studies comparing futibatinib to other treatments or combining it with other cancer drugs[5][6]
  • Research on its effectiveness in specific patient groups, such as those with certain genetic mutations[4]

Administration and Dosage

Futibatinib is typically taken orally as a tablet. The most common dosage being studied is 20 mg once daily[4][5]. However, the exact dosage may vary depending on the specific study or patient needs. It’s usually given in cycles, with each cycle lasting 21 or 28 days[1].

Side Effects and Safety

As with any medication, futibatinib can cause side effects. Common side effects being monitored in clinical trials include:

  • Increased phosphorus levels in the blood
  • Diarrhea
  • Fatigue
  • Dry mouth
  • Nausea
  • Changes in liver function tests

Researchers are closely monitoring patients for these and other potential side effects to ensure the drug’s safety[1][5].

Combination Therapies

Futibatinib is also being studied in combination with other cancer treatments to potentially enhance its effectiveness. Some notable combinations include:

  • Futibatinib with pembrolizumab (an immunotherapy drug) for urothelial cancer and liver cancer[5][2]
  • Futibatinib with binimetinib (a MEK inhibitor) for advanced cancers with KRAS mutations[6]

Future Prospects

Futibatinib shows promise in treating various types of cancer, especially those with specific genetic alterations. Ongoing research aims to:

  • Determine which patients are most likely to benefit from the treatment
  • Explore its effectiveness in different cancer types and stages
  • Investigate potential combinations with other cancer therapies
  • Assess long-term safety and efficacy

As research continues, futibatinib may become an important treatment option for patients with certain types of cancer, particularly those with FGFR gene alterations[3][4].

Aspect Details
Drug Name Futibatinib (also known as TAS-120)
Drug Class FGFR inhibitor
Administration Oral, typically 20 mg once daily
Main Cancer Types Studied Cholangiocarcinoma, breast cancer, urothelial cancer, solid tumors with FGFR alterations
Key Genetic Targets FGFR1, FGFR2, FGFR3, FGFR4 gene alterations
Primary Outcomes Measured Overall response rate, progression-free survival, safety profile
Common Side Effects Changes in phosphate levels, eye problems, fatigue, gastrointestinal issues
Combination Therapies Being studied with fulvestrant, binimetinib, pembrolizumab

FAQ

  • What is futibatinib? Futibatinib is an investigational drug that inhibits fibroblast growth factor receptors (FGFRs). It is being studied as a potential treatment for various advanced cancers, especially those with FGFR gene alterations.
  • What types of cancer is futibatinib being studied for? Futibatinib is being investigated for several cancer types, including cholangiocarcinoma (bile duct cancer), breast cancer, urothelial cancer, and other solid tumors with specific genetic mutations, particularly those involving FGFR genes.
  • How is futibatinib administered? In most clinical trials, futibatinib is given as an oral medication, typically taken once daily in continuous 28-day cycles. The common dose being studied is 20 mg per day.
  • What are the potential side effects of futibatinib? While specific side effects can vary, common adverse events observed in clinical trials include changes in phosphate levels, eye problems, fatigue, and gastrointestinal issues. The trials closely monitor patients for any side effects to assess the drug's safety profile.
  • How can I participate in a clinical trial for futibatinib? To participate in a futibatinib clinical trial, you would need to meet specific eligibility criteria, which often include having a particular type of cancer or genetic mutation. Speak with your oncologist about whether you might be eligible for any ongoing trials.

Ongoing Clinical Trials on Futibatinib

  • A study of futibatinib combined with tislelizumab, fluorouracil, calcium folinate, and oxaliplatin as first-line treatment for patients with colorectal cancer

    Recruiting

    2 1 1 1
    Investigated drugs:
    Germany

  • Study on Atezolizumab, Amivantamab, and Futibatinib for Patients with Advanced Solid Tumors

    Recruiting

    2 1 1 1
    Investigated drugs:
    France Germany Italy The Netherlands Spain Sweden

  • Study on the Long-Term Safety of Futibatinib and Fulvestrant for Patients with Malignant Solid Tumors

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Portugal Spain Sweden

  • Study of Futibatinib for Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Poland Portugal Spain

  • Study on Maintenance Therapy with Cisplatin, Durvalumab, and Trastuzumab for Patients with Advanced Biliary Cancer

    Recruiting

    3 1 1 1
    Investigated drugs:
    Belgium France

  • Study on Everolimus and Drug Combination for Children with Relapsed or Refractory Pediatric Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Italy The Netherlands Spain

  • Study on Advanced Soft-Tissue Sarcoma: Testing Futibatinib and Drug Combination for Patients with Unresectable or Metastatic Conditions

    Not recruiting

    3 1 1 1
    Investigated drugs:
    France

  • Study of Futibatinib with Pembrolizumab and Chemotherapy for Patients with Solid Tumors

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France Germany Spain

  • Study of Futibatinib and Pembrolizumab for Patients with Advanced or Metastatic Bladder, Urethra, or Pelvis Cancer Not Suitable for Platinum Treatment

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France

Glossary

  • Futibatinib: An investigational drug that inhibits fibroblast growth factor receptors (FGFRs), being studied for the treatment of various advanced cancers with specific genetic alterations.
  • FGFR: Fibroblast Growth Factor Receptor, a type of protein found on cells that plays a role in cell growth and division. Mutations in FGFR genes can contribute to cancer development.
  • Cholangiocarcinoma: A type of cancer that forms in the bile ducts, which are tubes that connect the liver to the small intestine.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Progression-free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by 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.

References

  1. https://clinicaltrials.gov/study/NCT02052778
  2. https://clinicaltrials.gov/study/NCT04828486
  3. https://clinicaltrials.gov/study/NCT03767075
  4. https://clinicaltrials.gov/study/NCT04189445
  5. https://clinicaltrials.gov/study/NCT04601857
  6. https://clinicaltrials.gov/study/NCT04965818
  7. https://clinicaltrials.gov/study/NCT05036681