Phase 2 Ovarian Cancer Trial, Recruiting NCT05377996 Sponsor: Day One Biopharmaceuticals, Inc. Condition: Ovarian Cancer
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Phase 2 Ovarian Cancer Trial, Recruiting

NCT05377996
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 a solid tumour (a type of cancer that forms a lump) that has come back or spread to other parts of the body
  • People who are well enough to carry out normal daily activities with little or no limitation (measured by a standard health scale called ECOG, scores 0 or 1)
  • People in a specific part of the trial (called DES) who have at least one tumour that can be measured on a scan, using standard measurement guidelines
  • People who have tumour tissue available from a previous sample, or who are willing to have a small tumour biopsy taken before treatment begins, if it is safe to do so
  • People with triple-negative breast cancer (TNBC), or those who have a history of cancer spreading to the brain or who have neurological symptoms, must have a brain MRI scan done during the screening period (or within 30 days before screening)

Who may not be able to join:

  • People who have previously been treated with a type of targeted cancer drug (called an Antibody Drug Conjugate, or ADC) that contains a specific ingredient called an auristatin payload
  • People who have had major surgery within 28 days before starting the study, or certain other cancer treatments within specified recent timeframes before starting the study (confirm with trial site for exact timeframes)
  • People who have been diagnosed with another cancer that needed active treatment such as surgery, radiation, or systemic therapy within the past 2 years — though some minor skin cancers and certain early-stage cancers may be exceptions
  • People who have untreated cancer that has spread to the brain, or a history of cancer spreading to the lining around the brain or spinal cord
  • People who have previously received treatment that specifically targeted a protein called B7-H4
  • People with a history of serious liver conditions, such as cirrhosis, liver scarring, or enlarged veins in the oesophagus or stomach caused by liver disease
  • People with a severe, uncontrolled illness affecting the heart, lungs, or metabolism, or any other serious ongoing condition that could raise the risk of harmful side effects or interfere with the trial
  • People with a clinically significant heart or blood vessel condition (confirm with trial site for specific details)
  • People with active inflammation of the cornea (the front surface of the eye)

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 20 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: Robert Burger, MD, Day One Biopharmaceuticals, Inc.

Phone: 1-650-484-0899

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
Day One Biopharmaceuticals, Inc.
Registry
ClinicalTrials.gov
Start date
15 August 2022
Est. completion
1 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with Emi-Le during the first cycle of treatment (Dose Escalation); Incidence of adverse events (Dose Escalation and Dose Expansion); Objective Response Rate (ORR) (Dose Expansion and EMBLEM-1)

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: 20 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