Phase 2 Endometrial Cancer Trial, Recruiting NCT03832361 Sponsor: Alessandro Santin Condition: Endometrial Cancer
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Phase 2 Endometrial Cancer Trial, Recruiting

NCT03832361
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 endometrial cancer that has come back or not gone away, confirmed by a CT scan and/or MRI.
  • People whose cancer is one of these specific types (confirmed by biopsy or pathology report): uterine serous carcinoma (pure or mixed), Grade 2 or Grade 3 endometrial adenocarcinoma, carcinosarcoma with certain high-grade components, or clear cell carcinoma (pure or mixed).
  • People whose cancer can be measured on scans, with at least one specific area that can be tracked to assess treatment response.
  • People whose tumour tests positive for a protein called FRα (folate receptor alpha), as defined by the trial's testing requirements.
  • People who have received no more than 3 prior treatment courses for recurring disease (hormonal treatments do not count toward this number), and who have not previously been treated with any folate receptor-targeting experimental drugs.
  • People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning largely able to carry out normal daily activities) (confirm with trial site).
  • People who have waited a sufficient amount of time since their last treatment — at least 5 half-lives or 4 weeks since systemic cancer treatment (whichever is shorter), and at least 4 weeks after wide-field radiotherapy or 2 weeks after focused radiotherapy.
  • People whose side effects from previous chemotherapy have resolved before starting the trial.
  • People with adequate blood, liver, and kidney function as defined by the trial's specific tests (confirm with trial site).
  • Women who could become pregnant must agree to use effective contraception during treatment and for at least 12 weeks after the last dose of the study drug.
  • Women who could become pregnant must have a negative pregnancy test within 4 days before the first dose.
  • People who had surgery for their cancer, whether or not all visible cancer was removed at that time.
  • People who are 18 years of age or older and have signed the consent form and are willing to follow the trial schedule and requirements.

Who may not be able to join:

  • People with an active or long-term corneal (eye surface) condition.
  • People with a serious ongoing illness or active infection, as defined by the trial's criteria (confirm with trial site).
  • People with significant heart conditions, such as a heart attack within the last 6 months, unstable chest pain, uncontrolled heart failure, uncontrolled high blood pressure, a history of hypertensive crisis, irregular heart rhythms, significant blood vessel disease, severe aortic valve narrowing, significant peripheral circulation problems, or heart damage from prior chemotherapy.
  • People with a history of neurological (nervous system) conditions (confirm with trial site for specifics).
  • People who have had a stroke (either bleeding or blockage type) within the last 6 months.
  • People with a history of cirrhosis (scarring of the liver).
  • People who have previously been diagnosed with non-infectious lung inflammation (pneumonitis).
  • People who have had a serious allergic reaction to monoclonal antibody treatments in the past.
  • People who are currently pregnant or breastfeeding.
  • People with cancer that has spread to the membranes around the brain or spinal cord, untreated brain metastases, or brain metastases causing symptoms.
  • People who have had blood clotting or bleeding disorders within 6 months before the first dose of the study treatment.
  • People who are required to take folate-containing supplements (for example, due to folate deficiency).
  • People who have another cancer that is growing or has required active treatment within the 3 years before the first dose of the study 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 16 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: Alessandro D. Santin, M.D., Yale University

Phone: 203-737-4450

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
Sponsor
Alessandro Santin
Registry
ClinicalTrials.gov
Start date
15 July 2020
Est. completion
1 October 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Objective 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: 16 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