Can a DNA-Based therapy revive Chemotherapy's power against resistant ovarian cancer?
NCT ID NCT05979298
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This phase 2 trial is investigating whether adding an experimental DNA-based therapy called ELENAGEN to the chemotherapy drug gemcitabine can help people with platinum-resistant ovarian cancer. The study will compare the combination against gemcitabine alone, measuring how long participants live without their cancer progressing. It aims to see if this approach is safe and potentially more effective than standard chemotherapy for this hard-to-treat condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ELENAGEN (a DNA plasmid) combined with gemcitabine chemotherapy
- What this could lead to
- If successful, this combination could offer a new treatment option for ovarian cancer that has stopped responding to platinum-based chemotherapy.
- What could go wrong
- This is a small, early-phase trial, so results may not be conclusive. The combination could also increase side effects without improving outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
40 people
The number who actually took part.
- Started
-
Nov 2019
- Finished
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Dec 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The patient is 18-70 years old. * Written informed consent of the patient to participate in clinical trials. * Presence of histologically confirmed ovarian cancer. * The return of the disease occurred less than 6 months after the last administration of platinum. * Presence of measurable tumor lesions according to RECIST 1.1 criteria. * Functional status according to ECOG scale is 0-2. * Life expectancy of at least 6 months. * Adequate function of the organs as determined by the following criteria: 1. Absolute number of neutrophils (ANN) ≥1500/mm3 (≥1.5 × 109/l); 2. Platelet count ≥100,000/mm3 (IU: ≥100 × 109/l). 3. Hemoglobin level ≥ 9.0 g/dL determined by analysis performed at least 2 weeks after the last hemotransfusion; 4. The level of AST and ALT in blood serum not exceeding more than 3 times the upper limit of the norm. 5. The level of serum bilirubin not exceeding more than 1.5 times the upper limit of normal. 6. Serum Creatinine ≤ 1.5 mg/dL. * The ability of the patient to follow the directions of the research physician and follow the study regimen. Exclusion Criteria: Criteria by which patients are not included in the study * Platinum-sensitive relapse of ovarian cancer (disease recurrence occurred more than 6 months after the last administration of platinum drugs). * Presence of serious diseases or health conditions: 1. Other malignancies, with the exception of malignancies treated more than 5 years ago without signs of return of the disease. 2. Brain metastases or leptomeningeal metastases. 3. Active infection (e.g. fever ≥38 °C), including active or unresolved pneumonia/pneumonitis. 4. Uncontrolled diabetes mellitus. 5. Myocardial Infarction in the last 12 months, severe/unstable angina, clinically manifested heart failure class III-IV according to the classification of the New York Cardiology Association (NYCA). 6. Gastrointestinal bleeding within the last 2 weeks. 7. Human immunodeficiency virus (HIV), chronic or acute hepatitis B or hepatitis C. 8. Patients with autoimmune disorders or organ transplantation who require immunosuppressive therapy. I. Mental illness that may increase the risk associated with participation in the study or taking the study drug or that may affect the interpretation of the results of the study. K. Polyallergy, bronchial asthma (including aspirin) in history. * Major surgery during the previous 4 weeks (complete wound healing). * Previous chemotherapeutic treatment of the patient according to the scheme GEMCITABINE * Radiotherapy with extended field radiation within the previous 4 weeks or radiotherapy with a limited field radiation within the previous 2 weeks.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Minsk City Clinical Oncology Center
Minsk, Belarus
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