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2-Amino-9-((2R,4R,5R)-4-Hydroxy-5-(Hydroxymethyl) Tetrahydrofuran-2-Yl)-1,4,5,9-Tetrahydro-6H-Purine-6-Thione

This article discusses the ongoing clinical trials investigating the use of THIO (2-Amino-9-((2R,4R,5R)-4-Hydroxy-5-(Hydroxymethyl) Tetrahydrofuran-2-Yl)-1,4,5,9-Tetrahydro-6H-Purine-6-Thione) in combination with cemiplimab for patients with advanced non-small cell lung cancer (NSCLC). The trials aim to assess the safety, tolerability, and effectiveness of this treatment approach in patients who have progressed after previous therapies.

Table of Contents

What is THIO?

THIO is a new medication being studied for the treatment of advanced non-small cell lung cancer (NSCLC). Its full chemical name is 2-Amino-9-((2R,4R,5R)-4-Hydroxy-5-(Hydroxymethyl) Tetrahydrofuran-2-Yl)-1,4,5,9-Tetrahydro-6H-Purine-6-Thione, which is quite a mouthful! It’s described as a “synthetically modified small molecule nucleoside,” which means it’s a specially designed drug that mimics parts of our genetic material.[1]

Medical Condition Treated

THIO is being studied to treat advanced non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer, accounting for about 80-85% of all lung cancers. “Advanced” typically refers to cancer that has spread beyond the lungs to other parts of the body (stage III or IV).[1]

How THIO Works

While the exact mechanism isn’t fully explained in the trial information, THIO is being studied in combination with another drug called cemiplimab (LIBTAYO®). Cemiplimab is an immunotherapy drug, which means it helps the body’s immune system fight cancer cells. The researchers are investigating whether THIO can enhance the effects of immunotherapy in patients whose cancer has progressed after previous treatments.[1]

Current Clinical Trial

THIO is currently being studied in a Phase 2 clinical trial. This trial is:

  • Multicenter: conducted at multiple hospitals or research centers
  • Open-label: both patients and doctors know which treatment is being given
  • Dose-finding: trying to determine the best dose of the drug
The main goals of this study are:
  1. To determine if THIO is safe and well-tolerated when given with cemiplimab
  2. To assess how effective THIO is in treating advanced NSCLC when combined with cemiplimab
[1]

Eligibility Criteria

To participate in this study, patients must meet certain criteria. Some key points include:

  • Be at least 18 years old
  • Have stage III or IV NSCLC that has progressed after previous treatment
  • Have received only one prior treatment for advanced NSCLC, which must have included an immunotherapy drug
  • Have at least one measurable tumor
  • Have good overall health and organ function
There are also several conditions that would prevent a person from participating, such as certain autoimmune diseases, untreated brain metastases, or active infections.[1]

Potential Side Effects

As this is an ongoing study, the full range of side effects isn’t yet known. However, the researchers are closely monitoring for any adverse events (negative side effects) during the trial. They’re particularly watching for what they call dose-limiting toxicities (DLTs), which are side effects severe enough to limit how much of the drug can be given safely.[1]

Conclusion

THIO represents a potential new treatment option for patients with advanced non-small cell lung cancer who have already tried other treatments. While it’s still in the research phase, this clinical trial will help determine if THIO is safe and effective when combined with immunotherapy. As always, patients should discuss any new treatment options with their healthcare provider to determine what’s best for their individual situation.[1]

Aspect Details
Study Type Multicenter, Open-Label, Dose-Finding, Phase 2 Study
Treatment THIO sequenced with Cemiplimab (LIBTAYO®)
Condition Advanced Non-Small Cell Lung Cancer (NSCLC)
Primary Objectives 1. Determine safety and tolerability
2. Assess efficacy
Key Eligibility Criteria – Stage 3 or 4 NSCLC
– Progressed after prior treatment
– One prior treatment including anti-PD-1/PD-L1 agent
– Measurable disease
– Adequate organ function
Primary Endpoints 1. Incidence of adverse events
2. Objective Response Rate (ORR)
3. Disease Control Rate (DCR)
THIO Administration Intravenous infusion, max daily dose 180 mg, max total dose 540 mg

FAQ

  • What is THIO and how is it being studied? THIO is a synthetically modified small molecule nucleoside being studied in combination with cemiplimab for the treatment of advanced non-small cell lung cancer. The clinical trial is designed to determine the safety, tolerability, and efficacy of this combination in patients whose cancer has progressed after previous treatments.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults (18 years or older) with stage 3 or 4 non-small cell lung cancer that has progressed or relapsed after previous treatment. They must have received only one prior treatment for NSCLC in the advanced setting, which included an anti-PD-1/PD-L1 agent. Participants must also have measurable disease and adequate organ function.
  • What are the main objectives of the study? The main objectives of the study are to determine the safety and tolerability of THIO when given in sequence with cemiplimab, and to assess the efficacy of this treatment combination in patients with advanced non-small cell lung cancer.
  • How is the effectiveness of the treatment measured? The effectiveness of the treatment is primarily measured by the objective response rate (ORR), which is the proportion of patients who achieve either a complete or partial response to the treatment. Additionally, the disease control rate (DCR) is assessed, which includes patients with complete response, partial response, or stable disease.
  • What are some of the key exclusion criteria for the study? Key exclusion criteria include having active autoimmune diseases, being pregnant or lactating, having untreated or symptomatic brain metastases, prior treatment with cemiplimab, and having active, uncontrolled infections. Patients with a history of another concurrent cancer or those who require high doses of corticosteroids are also excluded.

Ongoing Clinical Trials on 2-Amino-9-((2R,4R,5R)-4-Hydroxy-5-(Hydroxymethyl) Tetrahydrofuran-2-Yl)-1,4,5,9-Tetrahydro-6H-Purine-6-Thione

  • Study of THIO and cemiplimab compared to chemotherapy in patients with advanced non-small cell lung cancer who have received two previous treatments

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Hungary Poland Portugal Romania Spain

  • Study on THIO and Cemiplimab for Patients with Advanced Non-Small Cell Lung Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Hungary Poland Romania

Glossary

  • Non-Small Cell Lung Cancer (NSCLC): A type of lung cancer that is the most common form of lung cancer. It grows and spreads more slowly than small cell lung cancer.
  • THIO: A synthetically modified small molecule nucleoside being studied as a potential treatment for advanced non-small cell lung cancer.
  • Cemiplimab: An immunotherapy drug that helps the immune system fight cancer cells. It's being studied in combination with THIO in this clinical trial.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment. It includes both complete and partial responses.
  • Disease Control Rate (DCR): The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease to a therapeutic intervention in clinical trials.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Dose Limiting Toxicities (DLTs): Side effects of a drug that are serious enough to prevent an increase in dose or that require a decrease in dose in a clinical trial.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: A scale used to assess how a patient's disease is progressing and how the disease affects the patient's daily living abilities.
  • Immunotherapy: A type of cancer treatment that helps your immune system fight cancer. It is sometimes called biologic therapy.
  • Metastases: The spread of cancer cells from the place where they first formed to another part of the body.

References

  1. http://clinicaltrials.eu/trial/study-on-thio-and-cemiplimab-for-patients-with-advanced-non-small-cell-lung-cancer/