Can a DNA-Based therapy revive Chemotherapy's power against resistant ovarian cancer?

NCT ID NCT05979298

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Female participants only

Healthy volunteers

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

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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