Phase 2 Ovarian Cancer Trial, Recruiting NCT06040970 Sponsor: Icahn School of Medicine at Mount Sinai Condition: Ovarian Cancer
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Phase 2 Ovarian Cancer Trial, Recruiting

NCT06040970
Recruiting Phase 2

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:

  • People who have been diagnosed with epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer) or endometrial cancer, confirmed by a tissue or cell sample test
  • People whose cancer has come back more than 6 months after their last platinum-based chemotherapy treatment (called "platinum-sensitive" recurrence), with evidence of this return shown on scans
  • Women aged 18 or older
  • People who are in good general health, able to carry out daily activities with little or no difficulty (as measured by a standard health scale called WHO performance status 0–1), whose health has not declined in the past 2 weeks, and who are expected to live at least 12 weeks
  • People who have at least one area of cancer that can be measured or tracked on CT or PET/CT scans
  • People whose blood counts are at acceptable levels without needing a blood transfusion or medication to boost blood cell production in the 2 weeks before starting the study — including haemoglobin, white blood cell counts, and platelet levels meeting specific thresholds (confirm with trial site)
  • People whose liver, kidney, and overall organ function meet the required levels, including liver enzyme levels, bilirubin, blood protein (albumin), and kidney filtering ability (confirm with trial site)
  • Women who could potentially become pregnant must agree to use reliable contraception before joining, throughout the trial, and for 6 months after treatment ends — this includes any woman who has not had a hysterectomy or removal of both ovaries, or who has not gone through menopause for at least 12 consecutive months
  • People who are willing and able to understand and sign a written consent form

Who may not be able to join:

  • People who have received another experimental drug or taken part in a clinical trial within 28 days (or 5 half-lives of that drug, whichever is longer) before the first dose
  • People who have had any other chemotherapy, immunotherapy, or cancer treatment within 14 days before the first dose
  • People who have had major surgery (not including insertion of a vascular access line) within 4 weeks before the first dose
  • People who have had wide-field radiation therapy within 4 weeks, or limited palliative radiation within 2 weeks, before the first dose
  • People who still have significant side effects from previous cancer treatments (above a minor level), except for hair loss
  • People with severe or uncontrolled health conditions, including active bleeding disorders, uncontrolled infections, or active hepatitis B, hepatitis C, or HIV
  • People with a known severe allergic reaction (grade 3 or higher) to sacituzumab govitecan (SG) or cisplatin, or any of their ingredients
  • People with nerve damage in the hands or feet rated at grade 2 or above (causing noticeable symptoms)
  • People with ongoing severe nausea and vomiting, or chronic digestive system diseases
  • People who are pregnant or breastfeeding
  • Women who could potentially become pregnant and are unwilling to use effective contraception during the trial and for 6 months after treatment ends
  • People who have had unstable chest pain (angina), a heart attack, or heart failure within the past 6 months, or who have a significant heart rhythm problem requiring medication (stable atrial fibrillation is generally acceptable — confirm with trial site)
  • People with a significant active lung condition such as severe COPD or another moderate-to-severe chronic breathing illness present within the past 6 months
  • People who have had a significant bleeding episode, a bowel blockage, or a hole in the digestive tract within the past 6 months
  • People with other medical or mental health conditions that, in the trial doctor's opinion, could affect the trial results or prevent them from completing the trial
  • People who have previously been treated with sacituzumab govitecan, irinotecan, or certain similar antibody-based drug treatments at any time
  • People with active inflammatory bowel disease (such as ulcerative colitis or Crohn's disease), or a hole in the digestive tract within the past 6 months
  • People who need to continue taking any medications that are not permitted during the trial
  • People with active cancer that has spread to the brain or the lining around the brain — although people with previously treated and stable brain metastases for at least 4 weeks may be considered (confirm with trial site); anyone with cancer in the membrane around the brain is excluded regardless
  • People who currently have another active cancer — although people who have been cancer-free for 3 or more years, or who have had certain low-risk cancers fully removed, may be considered (confirm with trial site)
  • People who have received a live vaccine within 30 days before the first dose
  • People who have a serious active infection currently requiring antibiotic, antiviral, or antifungal treatment

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 22 July 2026
Phase 2: approximately ~30% 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.

Contact this trial

Principal Investigator: Amy Tiersten, MD, Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology

Phone: (212) 241-3300

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
23 October 2024
Est. completion
1 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Dose-limiting toxicity (DLT) at the maximum tolerated dose (MTD) for the Safety Run-In Phase; Dose limiting toxicity (DLT) for the DEC Phase; Overall Response Rate (ORR)

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: 22 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