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Tinengotinib

Tinengotinib, also known as TT-00420, is an investigational drug currently being studied in clinical trials for the treatment of various advanced solid tumors, with a particular focus on cholangiocarcinoma (bile duct cancer). These trials aim to evaluate the safety, efficacy, and potential benefits of Tinengotinib in patients who have not responded well to previous treatments. The ongoing research explores its use as a standalone therapy and in combination with other cancer treatments, offering hope for patients with limited treatment options.

Table of Contents

What is Tinengotinib?

Tinengotinib, also known by its research code TT-00420, is a new drug being studied for the treatment of various advanced cancers[1]. It is currently undergoing clinical trials to evaluate its safety and effectiveness in patients who have not responded well to other treatments.

What Conditions Does Tinengotinib Treat?

Tinengotinib is being investigated for the treatment of several types of cancer, including:

  • Advanced solid tumors: These are cancers that form solid masses in the body and have spread or become difficult to treat with standard therapies[1].
  • Cholangiocarcinoma: This is a rare type of cancer that starts in the bile ducts, which are tubes that connect the liver, gallbladder, and small intestine[2].
  • Metastatic castration-resistant prostate cancer (mCRPC): This is an advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy[3].

How Does Tinengotinib Work?

While the exact mechanism of action is not fully described in the provided information, Tinengotinib appears to target specific pathways involved in cancer growth. It is being studied in patients who have not responded well to other treatments, including chemotherapy and drugs that target a protein called FGFR (Fibroblast Growth Factor Receptor)[2]. This suggests that Tinengotinib may work differently from existing therapies, potentially offering a new option for patients with limited treatment choices.

Current Clinical Trials

Several clinical trials are currently underway to evaluate Tinengotinib:

  1. Rollover Study: This study allows patients who have benefited from Tinengotinib in previous trials to continue receiving the drug[1].
  2. Phase II Study in Cholangiocarcinoma: This trial is testing Tinengotinib in patients with cholangiocarcinoma who have not responded to chemotherapy and FGFR inhibitors[2].
  3. Phase Ib/II Study in Prostate Cancer: This study is evaluating Tinengotinib in combination with other drugs for the treatment of metastatic castration-resistant prostate cancer[3].
  4. Phase III Study in Cholangiocarcinoma: This large-scale trial is comparing Tinengotinib to standard treatments in patients with cholangiocarcinoma who have specific genetic alterations (FGFR-altered)[4].

How is Tinengotinib Administered?

Tinengotinib is taken orally as a tablet. The dosage and frequency may vary depending on the specific trial and patient needs. Some common dosages being studied include:

  • 10 mg once daily[2]
  • 8 mg once daily[4]

The medication is typically taken in cycles, with each cycle lasting 21 or 28 days[2][3].

Potential Side Effects

As Tinengotinib is still in clinical trials, the full range of potential side effects is not yet known. The trials are closely monitoring patients for any adverse events (side effects). These are categorized based on their severity using a standardized system called the Common Terminology Criteria for Adverse Events (CTCAE)[2][4].

Patients participating in clinical trials are carefully monitored for any side effects, and the dosage may be adjusted if necessary to ensure safety and tolerability.

Future Prospects

The ongoing clinical trials aim to determine several important aspects of Tinengotinib’s performance, including:

  • Objective Response Rate (ORR): This measures how many patients experience a significant reduction in tumor size[2].
  • Progression-Free Survival (PFS): This evaluates how long patients live without their cancer getting worse[2].
  • Overall Survival (OS): This measures how long patients live after starting treatment[2].
  • Duration of Response (DOR): This assesses how long the cancer remains controlled in patients who respond to the treatment[2].

If these trials show positive results, Tinengotinib could become an important new treatment option for patients with advanced cancers, particularly those who have not responded well to other therapies.

Aspect Details
Drug Name Tinengotinib (TT-00420)
Primary Conditions Studied Advanced Solid Tumors, Cholangiocarcinoma, Prostate Cancer
Administration Oral tablet, typically once daily
Dosages Studied 8 mg and 10 mg daily doses
Trial Phases Phase II and Phase III
Key Outcomes Measured Objective Response Rate (ORR), Progression-Free Survival (PFS), Overall Survival (OS), Safety and Tolerability
Combination Therapies Studied with abiraterone acetate/prednisone and enzalutamide for prostate cancer
Patient Population Adults with advanced solid tumors, focus on those who failed or relapsed after chemotherapy and FGFR inhibitor treatment

FAQ

  • What is Tinengotinib and what types of cancer is it being studied for? Tinengotinib, also known as TT-00420, is an investigational drug being studied for the treatment of advanced solid tumors, with a particular focus on cholangiocarcinoma (bile duct cancer). It is also being researched for use in prostate cancer.
  • How is Tinengotinib administered to patients in clinical trials? Tinengotinib is typically administered orally as a tablet, once daily. The dosage may vary depending on the specific trial, with some studies using 8 mg or 10 mg doses given in cycles of 21 or 28 days.
  • What are the main goals of the Tinengotinib clinical trials? The main goals of these trials are to evaluate the safety, efficacy, and tolerability of Tinengotinib. Researchers are looking at outcomes such as objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and the incidence and severity of side effects.
  • Are there any combination therapies being studied with Tinengotinib? Yes, some trials are investigating Tinengotinib in combination with other treatments. For example, one study is looking at Tinengotinib combined with androgen receptor signaling inhibitors (ARSIs) like abiraterone acetate and prednisone or enzalutamide for prostate cancer.
  • Who might be eligible to participate in Tinengotinib clinical trials? Eligibility varies by trial, but generally includes adult patients with advanced solid tumors, particularly those with cholangiocarcinoma who have not responded well to previous treatments such as chemotherapy and FGFR inhibitors. Some trials also focus on patients with specific genetic alterations, such as FGFR-altered cholangiocarcinoma.

Ongoing Clinical Trials on Tinengotinib

  • Study on the Effectiveness and Safety of Tinengotinib for Patients with Cholangiocarcinoma Resistant to Chemotherapy and FGFR Inhibitors

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Germany Italy Poland +2

Glossary

  • Cholangiocarcinoma: A type of cancer that forms in the bile ducts, which are tubes that connect the liver to the small intestine. It is also known as bile duct cancer.
  • FGFR: Fibroblast Growth Factor Receptor, a type of protein found on cells that plays a role in cell growth and division. Some cancers have alterations in FGFR genes.
  • 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.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • Overall Survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment.
  • CTCAE: Common Terminology Criteria for Adverse Events, a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.
  • QD: Once daily, referring to the frequency of taking medication.
  • Androgen Receptor Signaling Inhibitors (ARSIs): A class of drugs used to treat prostate cancer by blocking the effects of male hormones on cancer cells.

References

  1. https://clinicaltrials.gov/study/NCT06370013
  2. https://clinicaltrials.gov/study/NCT06057571
  3. https://clinicaltrials.gov/study/NCT06457919
  4. https://clinicaltrials.gov/study/NCT05948475