THIO + Cemiplimab for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment combination for non-small cell lung cancer (NSCLC) that has advanced or metastasized. It tests THIO (6-Thio-2'-Deoxyguanosine), a molecule targeting parts of cancer cells, with cemiplimab, an existing cancer drug. The goal is to determine if this combination benefits patients whose cancer has become resistant or returned after previous treatments. This trial may suit those with advanced NSCLC who have not succeeded with other treatments. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering hope for those seeking new options.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that THIO, when combined with cemiplimab, has been tested in patients with advanced non-small cell lung cancer (NSCLC) who have already tried other treatments. In a study involving 79 patients, this combination produced promising results after their cancer worsened despite at least two standard treatments. Safety information is still being collected, and the treatment is under study to assess its safety and effectiveness.
Cemiplimab, an FDA-approved drug for treating NSCLC, is known for its safety profile. Research has demonstrated that it helps patients with advanced NSCLC live longer. While it can cause immune-related side effects, these are usually manageable.
These findings offer some reassurance about the safety of using THIO and cemiplimab together, but ongoing studies are crucial to confirm these results.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of 6-Thio-2'-Deoxyguanosine (THIO) and cemiplimab for lung cancer because it offers a novel approach to treatment. Unlike the standard treatments for advanced/metastatic non-small cell lung cancer (NSCLC), such as chemotherapy and immunotherapy alone, this combination leverages the mechanism of THIO, which is designed to selectively target and destroy cancer cells by interfering with their DNA replication. Additionally, the sequential administration with cemiplimab, an immune checkpoint inhibitor, aims to enhance the immune system's ability to attack cancer cells more effectively. This innovative combination has the potential to provide a more targeted and robust response in patients who have not responded to other therapies.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
This trial will evaluate the combination of THIO and cemiplimab for treating non-small cell lung cancer (NSCLC). Studies have shown that cemiplimab, a PD-1 inhibitor, effectively treats NSCLC, particularly in patients with high levels of the protein PD-L1, significantly improving survival rates. THIO, another treatment in this trial, attacks the protective caps at the ends of DNA strands in cancer cells, causing them to die. Early research suggests that THIO can make cancer cells more responsive to treatments like cemiplimab. In one study, the combination of THIO and cemiplimab resulted in an average survival time of 16.9 months for patients with advanced NSCLC. This combination is expected to benefit those who have not responded to previous treatments.12367
Who Is on the Research Team?
Victor Zaporojan, MD
Principal Investigator
Maia Biotechnology
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive THIO followed by cemiplimab in a 3-week cycle, with dose variations across different parts of the study
Follow-up
Participants are monitored for safety and effectiveness after treatment, with radiographic assessments every 3 months for the first year, then every 6 months
Long-term follow-up
Participants are followed every 3 months until death, withdrawal of consent, or study termination
What Are the Treatments Tested in This Trial?
Interventions
- 6-Thio-2'-Deoxyguanosine
- Cemiplimab
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
To determine the efficacy of THIO 180 mg per cycle (60 mg on Days 1-3, sequenced with cemiplimab) when administered as third-line treatment in subjects with advanced/metastatic NSCLC.
To obtain clinical evidence of the efficacy and safety of the sequential combination of THIO 180 mg per cycle plus cemiplimab compared to single-agent THIO 180 mg per cycle as third-line treatment in subjects with advanced/metastatic NSCLC.
Cohort 1: THIO total 60 mg per cycle (20 mg on D1-3 Q3W) plus 350 mg cemiplimab on Day 5; Cohort 2: THIO total 180 mg per cycle (60 mg on D1-3 Q3W) plus 350 mg cemiplimab on Day 5; Cohort 3 (pending emerging data from Part A): THIO total 360 mg per cycle (120 mg on Days 1-3 Q3W) plus 350 mg cemiplimab on Day 5
Safety lead-in, modified 3+3 design. Part A: Cohort 1: THIO total 360 mg per cycle (120 mg on Days 1-3 Q3W) plus 350 mg cemiplimab on Day 5; Cohort 2 (pending emerging data from Cohort 1): THIO total 180 mg per cycle (60 mg on Days 1-3 Q3W) plus 350 mg cemiplimab on Day 5
Find a Clinic Near You
Who Is Running the Clinical Trial?
Maia Biotechnology
Lead Sponsor
Citations
2083eTiP A phase II study of ateganosine (THIO; 6- ...
Safety data and preliminary efficacy outcomes will be reported as they become available. Conclusion: THIO-101 aims to provide evidence on the potential of THIO ...
2.
ir.maiabiotech.com
ir.maiabiotech.com/news-events/press-releases/detail/155/maia-biotechnology-details-30-month-patient-survival-inMAIA Biotechnology Details 30-Month Patient Survival in ...
In addition, as of September 17, 2025, a patient that began therapy in March 2023 has shown survival of 30 months, or 912 days, an outstanding ...
563 A phase 3 study of ateganosine (THIO) sequenced ...
THIO (6-thio-2'-deoxyguanosine), a telomere-targeting agent, is selectively recognized by telomerase and integrated into the telomeres of cancer ...
Abstract B015: A Phase 2 Study of Ateganosine (THIO) in ...
Safety data and preliminary efficacy outcomes will be reported as they become available. Conclusion: THIO-101 aims to provide evidence on the ...
Induction of Telomere Dysfunction Mediated By the ... - PMC
Treatment with 6-thio-dG resulted in rapid cell death for the vast majority of the cancer cell lines tested, whereas normal human fibroblasts and human colonic ...
6.
onclive.com
onclive.com/view/ateganosine-sequenced-with-cemiplimab-displays-activity-in-pretreated-nsclcAteganosine Sequenced With Cemiplimab Displays ...
Ateganosine sequenced with cemiplimab was active in advanced NSCLC after disease progression on 2 or more standard therapies.
THIO Sequenced With Cemiplimab in Advanced NSCLC
The THIO-101 study evaluates the safety and efficacy of different doses of THIO sequenced with fixed dose of cemiplimab (referred to as investigational products ...
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