THIO Sequenced With Cemiplimab in Advanced NSCLC

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Maia Biotechnology
Study ID
NCT05208944
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 6-Thio-2'-Deoxyguanosine — DRUG
    small molecule telomere targeting agent
  • Cemiplimab — DRUG
    programmed cell death protein 1 (PD-1) inhibitor

Study Details

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 Dates

Start date
Jun 8, 2022
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
227 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A
    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
  • Experimental: Part B
    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
  • Experimental: Part C
    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.
  • Experimental: Part D
    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.

Primary Outcome Measure

To determine the safety and tolerability of THIO administered in sequence with cemiplimab in subjects with advanced NSCLC [ Time Frame: Up to 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Central Alabama ResearchBirminghamAlabama35209-
Summit HealthFlorham ParkNew Jersey07932-

Find similar trials in Birmingham, AL

By research site
Central Alabama Research· Birmingham, ALSummit Health· Florham Park, NJ

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