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Virus Therapy

Phase 1 for Small Cell Lung Cancer (Acclaim-3 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Genprex, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance >50 ml/min within ≤21 days

Documented history of histologically or cytologically confirmed ES-SCLC, prior to starting treatment with the combination of atezolizumab, carboplatin, and etoposide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 18 months

Awards & highlights

Acclaim-3 Trial Summary

This trial will test using a combination of quaratusugene ozeplasmid and atezolizumab as ongoing treatment for patients with Extensive Stage Small Cell Lung Cancer. The trial

Who is the study for?

This trial is for adults with Extensive Stage Small Cell Lung Cancer who've had a stable heart condition, responded well to initial cancer therapy without severe side effects, and have good physical functioning. They should not have recent major surgeries or active complications from past surgeries. Brain metastases must be treated and stable. Blood counts and organ functions need to be within certain limits.Check my eligibility

What is being tested?

The trial is testing quaratusugene ozeplasmid (Reqorsa) combined with atezolizumab as a maintenance treatment after initial success with chemotherapy in ES-SCLC patients. It's done in two parts: first to find the right dose and second to check how safe and effective it is.See study design

What are the potential side effects?

Possible side effects include immune-related reactions that can affect organs, fatigue, changes in blood tests reflecting liver or kidney function, potential infusion-related symptoms like fever or chills, and an increased risk of infections.

Acclaim-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is good, with creatinine levels at or below 1.5 mg/dL.

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My small cell lung cancer was confirmed by lab tests before starting treatment with atezolizumab, carboplatin, and etoposide.

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I agree to use two forms of birth control during and for 4 months after the study.

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My cancer has not worsened after 3-4 cycles of specific treatment.

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I am fully active or can carry out light work.

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My cancer has not worsened after 3-4 cycles of specific chemotherapy.

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I can perform all my usual activities without significant limitations.

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I have brain metastases but no recent seizures, completed treatment over 3 weeks ago, haven't used steroids for brain symptoms in over a week, and my last scans showed no worsening.

Acclaim-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) - Phase 1

Progression-Free Survival Rate (PFSR) - Phase 2

Secondary outcome measures

Overall Survival (OS) - Phase 1 & Phase 2

Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1 & Phase 2

Progression-free Survival (PFS) - Phase 1 & Phase 2

+1 more

Acclaim-3 Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment2 Interventions

Patients will be treated with the RP2D of quaratusugene ozeplasmid (IV administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) until disease progression or unacceptable toxicity

Group II: Phase 1Experimental Treatment2 Interventions

Up to 2 sequential dose selection cohorts will be treated with quaratusugene ozeplasmid (intravenous (IV) administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) until disease progression or unacceptable toxicity. Quaratusugene ozeplasmid doses will be evaluated (0.09 [starting dose], and 0.12 mg/kg) until the RP2D is identified.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

atezolizumab

2016

Completed Phase 2

~160

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genprex, Inc.Lead Sponsor

3 Previous Clinical Trials

363 Total Patients Enrolled

Mark S Berger, MDStudy DirectorGenprex, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being recruited for this research endeavor?

"Indeed, the details on clinicaltrials.gov highlight that this investigation is presently enrolling participants. The study was initially shared on February 1st, 2024 and underwent its latest revision on February 2nd, 2024. This trial aims to recruit a total of 62 subjects from two designated sites."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"Indeed, the information on clinicaltrials.gov indicates that this research study is actively seeking participants. It was initially listed on 2/1/2024 and last revised on 2/2/2024. The trial aims to enroll a total of 62 individuals spread across two locations."

Answered by AI

What are the main goals that this investigation aims to achieve?

"As per Genprex, Inc., the principal metric to be assessed during each dosage phase within the initial 21-day period is the Progression-Free Survival Rate (PFSR) for Phase 2. Additionally, this investigation will scrutinize secondary endpoints such as Progression-free Survival (PFS) encompassing Phases 1 and 2 using RECIST 1.1 criteria. PFS denotes the interval commencing from initiation of maintenance therapy until disease progression or mortality occurrence; Pharmacokinetics (PK) evaluation of Quaratusugene Ozeplasmid throughout Phases 1 and 2 involves monitoring quaratusug"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05703971.

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