RecruitingPhase 2NCT05208944

THIO Sequenced With Cemiplimab in Advanced NSCLC

A Multicenter, Open-Label, Dose-Finding, Phase 2 Study Evaluating THIO Sequenced With Cemiplimab (LIBTAYO®) in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)


Sponsor

Maia Biotechnology

Enrollment

227 participants

Start Date

Jun 8, 2022

Study Type

INTERVENTIONAL

Summary

THIO is a first-in-class small molecule telomere targeting agent, in development for the treatment of non-small cell lung cancer (NSCLC) in combination with cemiplimab (LIBTAYO®). THIO is preferentially incorporated into telomeres sequence in telomerase-positive cells leading to rapid telomere uncapping, genomic instability, and cell death. Cemiplimab is a programmed cell death protein 1 (PD-1) inhibitor recently approved as a first-line treatment for patients with locally advanced or metastatic NSCLC with 50% or more PD-L1 expression. It is hypothesized that THIO administration prior to cemiplimab would restore tumor responses to immunotherapy in subjects who either developed resistance or relapsed after receiving first line treatment with an immune check point inhibitor.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing THIO (a new drug that targets cancer cell telomeres — the protective caps on DNA) combined with cemiplimab (an immunotherapy drug) for people with advanced non-small cell lung cancer (NSCLC) that has stopped responding to prior immunotherapy. **You may be eligible if...** - You have stage 3 or 4 NSCLC confirmed by biopsy - Your cancer progressed after receiving immunotherapy (an anti-PD-1 or PD-L1 drug), and you initially had a response or stable disease for at least 6 months - You have not had targeted therapy for driver gene mutations - You are generally in good health (ECOG score of 0 or 1) - You are 18 years old or older **You may NOT be eligible if...** - You have untreated brain metastases - You have active bleeding in the gastrointestinal tract - You have a serious autoimmune disease that requires treatment - You have HIV, active hepatitis B, or hepatitis C - You have significant heart disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG6-Thio-2'-Deoxyguanosine

small molecule telomere targeting agent

DRUGCemiplimab

programmed cell death protein 1 (PD-1) inhibitor


Locations(35)

Central Alabama Research

Birmingham, Alabama, United States

Summit Health

Florham Park, New Jersey, United States

Sunshine Coast Haematology and Oncology Clinic

Buderim, Queensland, Australia

Cancer Research SA

Adelaide, South Australia, Australia

St. Vincent Hospital Melbourne

Fitzroy, Victoria, Australia

MHAT "HEART AND BRAIN" EAD Clinic of Medical Oncology

Pleven, Bulgaria

MC Synexus Sofia EOOD

Sofia, Bulgaria

MHAT "Serdika" EOOD

Sofia, Bulgaria

UMHAT "Sofiamed"

Sofia, Bulgaria

Semmelweis Egyetem Pulmonologiai Klinika

Budapest, Hungary

Országos Korányi Pulmonológiai Intézet

Budapest, Hungary

Orszagos Onkologiai Intezet

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont, Tudogyogyaszati Klinika

Debrecen, Hungary

Bács-Kiskun Megyei Oktatókórház, Onkoradiológiai Központ

Kecskemét, Hungary

Mátrai Gyógyintézet

Mátraháza, Hungary

Hetenyi Geza Korhaz, Onkologiai Kozpont

Szolnok, Hungary

Tüdőgyógyintézet Törökbálint, Onkológiai Osztályc

Törökbálint, Hungary

NZOZ FORMED 2 Sp. z o.o.

Oświęcim, Oswiecim, Poland

Centrum Onkologii im. prof. F. Lukaszczyka

Bydgoszcz, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Onkologii z Pododdzialem Diagnostyki Nowotworow Klatki Piersiowej

Krakow, Poland

Centrum Terapii Współczesnej J. M. Jasnorzewska

Lodz, Poland

NeuroMed

Lublin, Poland

Med Polonia Sp z o.o.

Poznan, Poland

Centrum Medyczne Mrukmed

Rzeszów, Poland

Centrum Medyczne Pratia

Skorzewo, Poland

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddzial Chemioterapii Nowotworow

Torun, Poland

Taipei Veterans General Hospital

Taipei, Beitou District, Taiwan

Chang-Gung Memorial Hospital - Linko

Taoyuan City, Guishan District, Taiwan

Tri-Service General Hospital

Taipei, Neihu District, Taiwan

Chang-Gung Memorial Hospital

Kaohsiung City, Niaosong District, Taiwan

Taipei Tzu Chi Hospital

New Taipei City, Xindian Dist, Taiwan

Taipei Medical University Hospital

Taipei, Xinyi District, Taiwan

National Taiwan University Hospital

Taipei, Zhongzheng District, Taiwan

Liv Hospital Ankara, Medikal Onkoloji Bilim Dalı

Ankara, Turkey (Türkiye)

İstinye Üniversitesi Hastanesi Liv Hospital Bahçeşehir

Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT05208944