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NCT05703971 · ClinicalTrials.gov registry record · Phase 1

Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients

A Phase 1 study of Small Cell Lung Cancer Extensive Stage, sponsored by Genprex.

Recruiting
Registry status
Phase 1
Development phase
62
Enrollment target
17
Study locations

NCT05703971: Recruiting Phase 1 study of Small Cell Lung Cancer Extensive Stage, sponsored by Genprex.

NCT05703971 is a Phase 1 study of Small Cell Lung Cancer Extensive Stage that is actively recruiting participants, run by Genprex. The registered enrollment target is 62 participants, above the 37-participant average among 3 other Small Cell Lung Cancer Extensive Stage trials with a reported enrollment target (68% higher). The trial reports 17 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05703971, a Phase 1 study of Small Cell Lung Cancer Extensive Stage, is actively recruiting participants, sponsored by Genprex.

RECRUITING
Registry status
Phase 1
Development phase
62 participants
Enrollment target
17
Study locations

Study Summary

This clinical trial will evaluate the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC). The study is comprised of 2 phases, a dose selection phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2).

Primary Outcome

The MTD and/or RP2D of the combination of quaratusugene ozeplasmid and atezolizumab. Note: if a MTD is not determined, the RP2D will be selected based on all available data (safety, PK, PD, and preliminary efficacy).

Interventions

  • BIOLOGICAL quaratusugene ozeplasmid
  • BIOLOGICAL atezolizumab

Study Locations (17)

Ohio

  • Gabrail Cancer Center Research - Canton
  • Oncology_Hematology Care Clinical Trials, LLC - Cincinnati
  • Oncology_Hematology Care Clinical Trials, LLC - Cincinnati
  • Oncology_Hematology Care Clinical Trials, LLC - Cincinnati
  • Oncology_Hematology Care Clinical Trials, LLC - Cincinnati
  • Oncology_Hematology Care Clinical Trials, LLC - Fairfield

Oregon

  • Willamette Valley Cancer Institute (Oregon) - Eugene
  • Northwest Cancer Specialists, P.C. - Portland
  • Providence Cancer Institute - Portland
  • Northwest Cancer Specialists, P.C. - Portland
  • Northwest Cancer Specialists, P.C. - Tigard

Texas

  • Texas Oncology - DFW - Dallas
  • Texas Oncology - Northeast Texas - Tyler

Colorado

  • Rocky Mountain Cancer Centers, LLP - Lone Tree

Missouri

  • Washington University School of Medicine - Siteman Cancer Center - St Louis

Virginia

  • Virginia Cancer Specialists, PC - Fairfax

Washington

  • Northwest Cancer Specialists, P.C. - Vancouver

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2024-05-09
Est. Completion 2027-08
Phase Phase 1
Genprex

4 total trials

What NCT05703971 shows while recruiting

NCT05703971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, above the 37-participant average among 3 other Small Cell Lung Cancer Extensive Stage trials with a reported enrollment target (68% higher).

The record links to 1 condition, with Small Cell Lung Cancer Extensive Stage appearing as the primary indexed condition, and to 2 interventions - of which quaratusugene ozeplasmid is the first listed.

NCT05703971 lists 17 locations in 7 states (Ohio, Oregon, Texas).

Frequently Asked Questions

What is clinical trial NCT05703971 about?

NCT05703971 is a clinical study titled "Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients". This clinical trial will evaluate the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC). The study is comprised of 2 phases, a dose selection phase (Phase 1) and a safety and efficacy evaluation phase ...

What is the current status of trial NCT05703971?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2024-05-09. Estimated completion is 2027-08.

What conditions does trial NCT05703971 study?

This clinical trial studies the following conditions: Small Cell Lung Cancer Extensive Stage.

What interventions are being tested in trial NCT05703971?

The interventions under investigation include: quaratusugene ozeplasmid (BIOLOGICAL), atezolizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT05703971?

This trial is sponsored by Genprex, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05703971 being conducted?

This trial has 17 study locations across Colorado, Missouri, Ohio, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05703971, the US trial registry maintained by the National Library of Medicine. NCT05703971 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.