Phase 2 Ovarian Cancer Trial, Recruiting NCT06993844 Sponsor: Ensem Therapeutics Condition: Ovarian Cancer
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Phase 2 Ovarian Cancer Trial, Recruiting

NCT06993844
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 with a solid tumour that has spread to other parts of the body or cannot be surgically removed, and has continued to grow or spread after at least one previous treatment.
  • People whose tumour has a specific gene change called a PIK3CA activating mutation, found through a test of tumour tissue or a blood test.
  • People who have at least one tumour that can be measured or assessed using standard imaging criteria (called RECIST v1.1).
  • People who are generally well enough to carry out light activity and care for themselves, based on a standard health rating scale (ECOG score of 0 or 1).
  • People whose liver, kidneys, and other organs are functioning well enough to meet the trial's requirements.
  • For certain parts of the trial (Parts B and C only): People with hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer that has spread or cannot be surgically removed with the goal of cure, and who have already received at least one CDK4/6 inhibitor treatment and at least one anti-oestrogen therapy.

Who may not be able to join:

  • People who have had a different type of cancer (solid tumour or blood cancer) within the past two years.
  • People who have brain or spinal metastases causing symptoms, or whose cancer has spread to the central nervous system and has not been treated or is not well controlled.
  • People who have been diagnosed with Type 1 diabetes, or who have Type 2 diabetes that is not well controlled.
  • People who have received any cancer treatment (standard or experimental) within 14 days before the start of the trial treatment.
  • People who still have side effects from previous cancer treatments that have not returned to their normal baseline levels (hair loss and nerve-related symptoms are exceptions to this rule).
  • People who have had radiation therapy to areas other than the target tumour within 14 days before the start of the trial 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 23 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

Phone: 1-617-383-4993

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
Ensem Therapeutics
Registry
ClinicalTrials.gov
Start date
10 June 2025
Est. completion
30 June 2027

Where this trial is recruiting

🇨🇳 China 🇺🇸 United States

Primary endpoints

Evaluate Safety and Tolerability of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B; Evaluate Safety and Tolerability of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B; Select the Recommended Phase 2 Dose(s) (RP2D) in Part B to be further explored in Part C (combination therapy expansion); Evaluate efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C

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: 23 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