Phase 1 Ovarian Cancer Trial, Recruiting NCT06586957 Sponsor: NiKang Therapeutics, Inc. Condition: Ovarian Cancer
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Phase 1 Ovarian Cancer Trial, Recruiting

NCT06586957
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 an advanced cancer that cannot be removed by surgery or has spread to other parts of the body, and your cancer has continued to grow despite your most recent standard treatment
  • Your cancer is one of the following types: ovarian cancer, endometrial cancer (a specific subtype may need a particular gene change called CCNE1 amplification), stomach/esophageal cancer with CCNE1 amplification, small cell lung cancer, triple-negative breast cancer, hormone receptor-positive/HER2-negative breast cancer, or another solid tumor with CCNE1 amplification (confirm with trial site for full list)
  • Depending on which part of the trial you are joining, you may need to have received a specific number of previous treatments — the exact number varies by cancer type, so confirm with the trial site
  • For hormone receptor-positive/HER2-negative breast cancer: you must have previously received a CDK4/6 inhibitor and hormone therapy, and hormone therapy is no longer considered suitable for you
  • Your liver, kidneys, and other organs are functioning well enough to participate (confirm with trial site)
  • If you are able to become pregnant, you must be willing to use a highly effective form of birth control, or you are post-menopausal or have had surgery that means you cannot become pregnant
  • You are able to swallow tablets or capsules
  • You agree to provide a stored tumor tissue sample and a new tumor biopsy before starting treatment

Who may not be able to join:

  • Your cancer could potentially be cured with surgery, radiation therapy, or chemotherapy
  • You have a history of another cancer (some exceptions may apply — confirm with trial site)
  • You have a history of certain rare immune system conditions affecting the lymph system or blood cells (confirm with trial site)
  • You have not yet recovered from significant side effects of your previous cancer treatments
  • You have had a serious heart or cardiovascular event (such as a heart attack or stroke) within the past 6 months
  • You have active cancer that has spread to the brain or the lining around the brain
  • You currently have active lung inflammation (interstitial lung disease) that requires treatment
  • You have a history of eye conditions such as uveitis, retinopathy, or other significant eye or corneal problems
  • You are still recovering from a major surgery within the past month, or a minor surgery within the past 10 days
  • You have HIV, or an active hepatitis B or C infection
  • You have previously been treated with a CDK2 inhibitor (a specific type of targeted cancer drug) — confirm with trial site if unsure
  • You have moderate or severe liver cirrhosis or another significant liver condition
  • You have received radiation therapy to relieve symptoms within the past 14 days, or any other radiation therapy within the past 4 weeks

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 30 June 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
NiKang Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
19 September 2024
Est. completion
1 January 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Participants with Dose Limiting Toxicity (DLT) events; 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: 30 June 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