Phase 1 Ovarian Cancer Trial, Recruiting NCT06964009 Sponsor: Elizabeth Stover, MD, PhD Condition: Ovarian Cancer
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Phase 1 Ovarian Cancer Trial, Recruiting

NCT06964009
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has come back or stopped responding to treatment, confirmed by a tissue biopsy.
  • You have at least one tumor that can be measured on a scan or X-ray (at least 1 cm on a CT or MRI scan, or at least 2 cm on a chest X-ray).
  • You have previously received at least one chemotherapy treatment containing platinum (such as carboplatin or cisplatin) for your cancer.
  • Your cancer got worse within 6 months of your last platinum-based chemotherapy treatment (this is called platinum-resistant disease).
  • You are 18 years of age or older.
  • Your general health and ability to carry out daily activities meets a certain minimum level (confirm with trial site).
  • Your blood counts, liver function, kidney function, and other lab results are within acceptable ranges (confirm with trial site for specific numbers).
  • If you are living with HIV, your immune cell count is healthy, your virus levels are undetectable, and you are on effective HIV treatment with no serious HIV-related infections in the past year.
  • If you have had a past hepatitis B or C infection, it has been treated and the virus is no longer detectable in your blood.
  • If you have had or currently have another type of cancer, it is either fully treated (at least 2 years ago with no signs of return) or is stable and not currently requiring treatment.
  • If you are able to become pregnant, you must agree to use effective contraception during the study and for at least 3 months after the last dose of study treatment.
  • You are able to understand and sign a consent form, or have a legal representative who can do so on your behalf.

Who may not be able to join:

  • You have previously received weekly paclitaxel chemotherapy for ovarian cancer that had already come back (though having it as part of your very first treatment may be allowed — confirm with trial site).
  • You have previously been treated with a type of drug called a BCL-XL inhibitor (such as navitoclax).
  • You are currently taking part in another clinical trial or have received an experimental treatment very recently.
  • You still have significant side effects from a previous cancer treatment (other than hair loss) that have not fully resolved.
  • You are currently taking high-dose steroids (such as prednisone above 10 mg per day) or long-term immune-suppressing medications.
  • Your cancer has spread to the brain or spinal fluid and is currently active (previously treated and stable brain metastases may be allowed — confirm with trial site).
  • You have had an organ transplant or certain types of immune cell therapy (some stem cell transplant histories may be allowed — confirm with trial site).
  • You had a major surgery within the past 8 weeks.
  • You have had a serious bowel blockage within the past 8 weeks.
  • You have had a build-up of fluid in your abdomen or lungs that needed repeated draining in the past 4 weeks.
  • You depend on IV nutrition or regular IV fluids to stay nourished.
  • You have an active infection that is moderate or severe, within 2 weeks before starting treatment.
  • You have a heart condition involving an abnormal heart rhythm measurement on an ECG, or a history of a specific heart rhythm disorder called Long QT Syndrome (confirm with trial site).
  • You have had a significant bleeding episode in the past 4 weeks, or have a condition that makes you prone to serious bleeding.
  • You have serious uncontrolled health conditions such as heart failure, unstable chest pain, heart arrhythmia, or are currently on dialysis or an organ transplant waiting list.
  • You have had a serious allergic reaction to paclitaxel or similar drugs and have not been able to tolerate it again afterward (those who have successfully received paclitaxel after a prior reaction may still be eligible — confirm with trial site).
  • You are currently taking certain medications that strongly affect how the study drugs are broken down by the body (called strong CYP3A4 or CYP2C8 inhibitors or inducers — confirm with trial site for specific medications).
  • You are pregnant or breastfeeding, as the study drugs may harm an unborn baby or nursing infant.

**Important: Always verify eligibility with the trial site directly before applying

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Elizabeth Stover, MD, PhD
Registry
ClinicalTrials.gov
Start date
22 September 2025
Est. completion
30 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

DT2216 Maximum Tolerated Dose (MTD); Number of Participants Experiencing a Dose-Limiting Toxicity (DLT)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov