A Phase 1/2 Clinical Trial of Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female aged ≥18 years.

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

• Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after receiving at least three cycles, and no more than four cycles, of atezolizumab, carboplatin, and etoposide.

• Eastern Cooperative Oncology Group performance status (ECOG PS) score from 0 to 1.

• Must be ≥28 days beyond major surgical procedures such as thoracotomy, laparotomy, or joint replacement, and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery per Investigator assessment.

• Asymptomatic brain metastases must meet ALL criteria of the following (a-d):

‣ No history of seizures in the preceding six months.

⁃ Definitive treatment must be completed ≥21 days prior to enrollment.

⁃ Must be off steroids administered because of brain metastases or related symptoms for ≥7 days.

⁃ If had previous brain irradiation, post-treatment imaging must demonstrate stability or regression of the brain metastases.

• Absolute neutrophil count (ANC) \>1500/mm3, platelet count \>100,000/mm3 within ≤28 days.

• Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance \>50 ml/min within ≤28 days.

• Adequate hepatic function as documented by serum bilirubin \<1.5 mg/dL and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X upper limit of normal (ULN) within ≤28 days.

• Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤28 days.

• If female of childbearing potential (FOCBP), must have negative serum pregnancy test (serum beta-human chorionic gonadotropin \[β-hCG\]) within ≤7 days of first dose.

• FOCBP and non-sterile men who are sexually active with FOCBP must agree to use two forms of contraception including one highly effective and one effective methods beginning ≥2 weeks prior to enrollment through for four months following the last dose of study treatment.

• If male, must agree to no sperm donation during study treatment and for an additional four months following the last dose of study treatment.

• Must have voluntarily signed an informed consent in accordance with institutional policies.

Locations
United States
Colorado
Rocky Mountain Cancer Centers, LLP
RECRUITING
Lone Tree
Missouri
Washington University School of Medicine - Siteman Cancer Center
RECRUITING
St Louis
Ohio
Oncology_Hematology Care Clinical Trials, LLC
RECRUITING
Cincinnati
Oncology_Hematology Care Clinical Trials, LLC
RECRUITING
Cincinnati
Oncology_Hematology Care Clinical Trials, LLC
RECRUITING
Cincinnati
Oncology_Hematology Care Clinical Trials, LLC
RECRUITING
Cincinnati
Oncology_Hematology Care Clinical Trials, LLC
RECRUITING
Fairfield
Oregon
Willamette Valley Cancer Institute (Oregon)
RECRUITING
Eugene
Northwest Cancer Specialists, P.C.
RECRUITING
Portland
Northwest Cancer Specialists, P.C.
RECRUITING
Portland
Providence Cancer Institute
RECRUITING
Portland
Northwest Cancer Specialists, P.C.
RECRUITING
Tigard
Texas
Texas Oncology - DFW
RECRUITING
Dallas
Texas Oncology - Northeast Texas
RECRUITING
Tyler
Virginia
Virginia Cancer Specialists, PC
RECRUITING
Fairfax
Washington
Northwest Cancer Specialists, P.C.
RECRUITING
Vancouver
Contact Information
Primary
Sr Director, Clinical Operations
kcombs@genprex.com
1-877-774-GNPX
Backup
Chief Medical Officer
mberger@genprex.com
1-877-774-GNPX
Time Frame
Start Date: 2024-05-09
Estimated Completion Date: 2027-08
Participants
Target number of participants: 62
Treatments
Experimental: Phase 1
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.
Experimental: Phase 2
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) or atezolizumab and hyaluronidase-tqjs (15 mL subcutaneous \[SQ\] administration once every 21 days) until disease progression or unacceptable toxicity
Sponsors
Leads: Genprex, Inc.

This content was sourced from clinicaltrials.gov

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