Phase 2 Ovarian Cancer Trial, Recruiting NCT06560112 Sponsor: Akeso Condition: Ovarian Cancer
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Phase 2 Ovarian Cancer Trial, Recruiting

NCT06560112
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:

  • Women aged 18 or older who have signed a written consent form to take part in the study.
  • People with a good to near-normal level of physical functioning (able to carry out daily activities with little or no limitation).
  • People with a life expectancy of at least 3 months.
  • People who have been diagnosed with a specific type of high-grade ovarian, fallopian tube, or primary peritoneal cancer (including high-grade serous, clear cell, or grade 3 endometrioid types) that has come back after platinum-based chemotherapy.
  • People whose cancer returned 6 or more months after finishing platinum-based chemotherapy, who have already received 3 or more lines of treatment, and for whom further platinum-based treatment is not considered appropriate.
  • People whose cancer came back within 6 months of finishing platinum-based chemotherapy, who have received 3 or fewer previous lines of treatment.
  • People whose cancer can be measured on scans, as assessed by the trial site team using standard criteria (RECIST v1.1).
  • People who are able to provide a stored tumour tissue sample (a specific type called FFPE).
  • People whose liver, kidneys, and other organs are functioning at an adequate level.
  • People of reproductive potential who agree to use effective contraception during the study and for 6 months after the last dose of the study treatment.

Who may not be able to join:

  • People whose ovarian cancer is of certain other types, such as mucinous, low-grade serous, carcinosarcoma, or sex cord stromal cell tumour.
  • People who have cancer that has spread to the brain or the lining around the brain.
  • People who have fluid build-up around the lungs, heart, or abdomen that cannot be controlled and requires repeated draining.
  • People who have had another active cancer in the 3 years before joining the trial.
  • People who have received systemic anti-cancer treatment within 3 weeks before joining the trial.
  • People who have previously received any treatment that works by targeting the body's immune system to fight cancer.
  • People who have had major surgery, an open biopsy, or a significant injury within 4 weeks before joining the trial, or who are expected to need major surgery during the study.
  • People with an autoimmune disease that is currently active or likely to return.
  • People who have needed regular steroid medication (above a certain dose) or other immune-suppressing medicines within 14 days before joining the trial.
  • People who have received a live vaccine within 4 weeks before joining the trial.
  • People with a known immune system deficiency, including those who test positive for HIV.
  • People who have had an organ transplant or a stem cell transplant from a donor.
  • People with a known history of scarring or inflammation of the lung tissue, or non-infectious lung inflammation.
  • People who have had a serious infection requiring hospitalisation.
  • People with a current active infection requiring systemic treatment.
  • People with active hepatitis B or active hepatitis C infection.
  • People with active or diagnosed inflammatory bowel disease or active diverticulitis.
  • People with significant heart or brain blood vessel disease.
  • People who still have unresolved side effects from previous cancer treatments.
  • People with a history of severe allergic reactions to monoclonal antibody treatments.
  • People who are pregnant or currently breastfeeding.
  • People who, in the investigator's judgement, have any condition that could put them at risk from the study treatment.
  • For certain groups within the trial (Cohorts 1, 2, and 4): People with known allergies or medical reasons preventing the use of specific chemotherapy drugs (PLD, paclitaxel, or topotecan).
  • For certain groups within the trial (Cohorts 2, 3, and 4): People with known allergies to components of a specific study drug (AK112) or conditions that could affect their safety when receiving it (confirm with trial site).

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

Phone: (0760)89873999

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
Akeso
Registry
ClinicalTrials.gov
Start date
12 November 2024
Est. completion
1 May 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by investigator

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