THIO Sequenced With Cemiplimab in Advanced NSCLC

Running, not enrolling · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT05208944

Run by

Maia Biotechnology

People needed

227

Starts

2022-06-08

Expected to finish

2027-12-31

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Have not recovered from adverse events (must be Grade ≤ 1) due to prior anti-cancer treatment.
• Untreated or symptomatic central nervous system (CNS) metastases. Note: subjects with treated asymptomatic brain metastasis are eligible.
• Active gastrointestinal bleeding as evidenced by either hematemesis or melena.
• History of another concurrent malignancy other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years.
• A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, adrenal replacement doses 10 mg daily prednisone equivalents, and systemic corticosteroids to manage adverse events (AEs) are permitted in the absence of active autoimmune disease.
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy within 2 weeks of screening.
• Positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active hepatitis B or hepatitis C.
• Significant cardiovascular impairment (history of New York Heart Association Functional Classification System Class III or IV) or a history of myocardial infarction or unstable angina within the past 6 months prior to IP initiation.
• a) QTcF > 480 msec at screening (based on average of triplicate ECGs at baseline).
• i. If the QTc is prolonged in a subject with a pacemaker or bundle branch block, the subject may be enrolled in the study if confirmed by the Medical Monitor.
• Ongoing immune-related/stimulated adverse events (irAEs) from other agents or required permanent discontinuation of prior ICIs due to irAEs. Subjects with resolved irAE may be allowed to enroll following consultation with Sponsor's Medical Monitor (or designee).
• Active autoimmune diseases or history of autoimmune diseases that may relapse, with the following exceptions:
• Controlled type 1 diabetes;
• Hypothyroidism (provided it is managed with hormone replacement therapy only);
• Controlled celiac disease;
• Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia);
• Any other disease that is not expected to recur in the absence of external triggering factors.
• Pregnancy or lactating.
• A serious nonmalignant disease (e.g., psychiatric, substance abuse, uncontrolled intercurrent illness, etc.) that could compromise protocol objectives in the opinion of the investigator and/or the Sponsor.
• Any other condition that, in the opinion of the investigator, would prohibit the subject from participating in the study.
• Prior Therapy
• Part C and Part D: more than two prior systemic treatments for advanced disease.
• Prior chemotherapy and/or non-biologic targeted therapy within 4 weeks, or biologic targeted therapy, immunotherapy, and/or radiation therapy within 6 weeks prior to Cycle 1 Day 1. Subjects who receive targeted radiation therapy for localized palliative care may be eligible to start treatment < 6 weeks with Medical Monitor agreement.
• Part A and Part B: Prior treatment with cemiplimab. Note: Part C and Part D: prior cemiplimab is permitted.
• For subjects who have received prior treatment with an ICI: primary resistance to prior ICI therapy, as defined by the SITC IRTF (Kluger 2020):

Where it is running

• 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

Full record on ClinicalTrials.gov

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