Early Phase 1 Ovarian Cancer Trial, Recruiting NCT06660511 Sponsor: Second Xiangya Hospital of Central South University Condition: Ovarian Cancer
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Early Phase 1 Ovarian Cancer Trial, Recruiting

NCT06660511
Recruiting Early 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 are willing to take part, have signed a consent form, and are able to follow the study requirements
  • You are 18 years of age or older
  • You have been diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, confirmed by a tissue or cell sample
  • A tumor tissue sample is available for testing, and results show a specific protein called HER2 is present at certain levels (IHC 1+, 2+, or 3+)
  • You are generally active and able to care for yourself (confirm with trial site)
  • Your life expectancy is expected to be more than 12 weeks
  • Your heart, bone marrow, liver, and kidneys are functioning well enough, based on blood tests
  • You have at least one measurable area of cancer that can be tracked on scans
  • If you could become pregnant, you must either have been surgically sterilised, have been through menopause for at least one year, or have a negative pregnancy test before starting and agree to use an approved method of contraception throughout the study, and must not be breastfeeding

Who may not be able to join:

  • You have previously been treated with certain types of targeted cancer drugs called HER2 ADC drugs, or similar drugs like anlotinib hydrochloride
  • Your cancer did not respond to platinum-based chemotherapy from the start
  • You have untreated cancer that has spread to the brain or the lining of the brain, or a history of cancer in the membranes surrounding the brain
  • You have symptoms of a bowel blockage and need fluids or nutrition given directly into a vein
  • You have a history of significant bleeding, any bleeding event of grade 3 or above in the past 4 weeks, or you have wounds, fractures, active stomach ulcers, or certain digestive conditions that have not healed
  • You have had a serious blood clot event in the past 6 months, such as a stroke, deep vein clot, or pulmonary embolism (note: people on preventative blood-thinning treatment may still be eligible — confirm with trial site)
  • You have serious heart or blood vessel problems, including a history of heart failure, dangerous irregular heart rhythms, angina, recent heart attack, significant heart valve disease, or very poorly controlled high blood pressure
  • Side effects from previous cancer treatments have not yet settled down to a mild or absent level (except for hair loss)
  • You have had major surgery within the past 4 weeks and have not fully recovered, or you are expected to need surgery during the study
  • You have had another type of cancer within the past 3 years (some exceptions apply for certain treated skin cancers and other fully treated cancers with no signs of return — confirm with trial site)
  • Scans show the tumour has grown into, or is very likely to grow into, major blood vessels in a way that could cause serious bleeding
  • You have fluid build-up in the chest, heart, or abdomen that requires repeated draining, or you have had it drained within the past month
  • You have a known allergy to any of the ingredients in the study medication
  • You are currently pregnant or breastfeeding
  • You have other serious health conditions or any other reason the trial doctor feels makes the study unsuitable for you

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
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

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Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Second Xiangya Hospital of Central South University
Registry
ClinicalTrials.gov
Start date
15 October 2024
Est. completion
1 September 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective response rate (ORR): The proportion of subjects whose best overall response rate (BOR) is evaluated as complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.

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