Phase 2 Ovarian Cancer Trial, Recruiting NCT05955105 Sponsor: Innolake Biopharm Condition: Ovarian Cancer
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Phase 2 Ovarian Cancer Trial, Recruiting

NCT05955105
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:

  • Adults between 18 and 80 years old.
  • People who have been diagnosed with an advanced or spreading solid tumour (confirmed through a tissue or cell sample), for whom no effective standard treatment is available.
  • People whose general physical functioning is rated at a certain level — specifically, a score of 2 or less on a standard scale used by doctors to measure how cancer affects daily activities (confirm with trial site).
  • People with a life expectancy of at least 3 months.
  • People whose cancer can be measured or tracked, either through scans or specific markers in the blood.
  • People whose blood test results at the screening stage meet specific levels for white blood cells, platelets, haemoglobin, liver function, kidney function, and blood clotting (confirm with trial site for exact values).
  • People whose heart is pumping at least 50% of its capacity, and whose heart rhythm measurements fall within specific ranges (confirm with trial site).
  • Women who could become pregnant must have a negative pregnancy test at screening.
  • People who are sexually active and could father or become pregnant must agree to use effective contraception throughout the study and for 90 days after the last dose, or must have had a surgical procedure that prevents pregnancy.
  • People who are able to give written informed consent before any trial-related screening begins.

Who may not be able to join:

  • People who have received systemic cancer treatments such as chemotherapy, radiation, biological therapies, hormone therapy, targeted therapy, or immunotherapy within the past 3 weeks (with some exceptions for certain specific treatments — confirm with trial site).
  • People who have taken part in another clinical trial and received an experimental treatment within the past 4 weeks.
  • People with certain gut conditions, such as Crohn's disease, ulcerative colitis, or short gut syndrome, that could affect how the body absorbs the study drug.
  • People with uncontrolled fluid build-up in body cavities (confirm with trial site).
  • People whose cancer has spread to the brain and is causing symptoms, requires steroid treatment, involves a lesion of 1.5 cm or larger, or shows signs of growth in the past 4 weeks.
  • People with serious heart conditions, including significant heart failure, unstable chest pain, irregular heart rhythm, a heart attack in the past 6 months, or a blood clot or pulmonary embolism in the past 3 months.
  • People who have risk factors for a specific type of abnormal heart rhythm called QT prolongation, including a personal or family history of long QT syndrome, or who are taking any medication known to cause this (confirm with trial site).
  • People with poorly controlled long-term conditions, including diabetes with a blood sugar marker (HbA1c) of 8.5% or higher, poorly controlled high blood pressure, a history of hypertensive emergency or brain swelling from high blood pressure, or hormonal conditions requiring ongoing systemic treatment.
  • People currently diagnosed with a lung condition called interstitial pneumonia, or with a history of chronic emphysema, COPD, or tuberculosis.
  • People who have needed systemic treatment for an autoimmune disease within the past 2 years (some exceptions apply, such as stable vitiligo, asthma, or thyroid conditions managed with replacement therapy — confirm with trial site).
  • People who have an active infection currently requiring antibiotic treatment through a drip (intravenous).
  • People known to have HIV infection.
  • People with an active hepatitis B infection (as defined by specific blood test results) or active hepatitis C infection (confirm with trial site for exact definitions).
  • People known to have syphilis.
  • People who have taken steroid medications at a dose equivalent to 10 mg or more of prednisone per day, or other immune-modifying treatments, within the past 14 days.
  • People who plan to receive a live vaccine at any point from 4 weeks before the first dose until 6 months after the last dose.
  • People who have had major surgery within the past 4 weeks.
  • People who have previously had a bone marrow transplant from a donor or a solid organ transplant.
  • People with a known history of a psychiatric condition, or alcohol or drug misuse, that could affect their ability to follow the trial requirements.
  • People who still have unresolved side effects from previous cancer treatments above a mild level (some exceptions apply, such as hair loss, nerve-related symptoms, or manageable thyroid changes — confirm with trial site).
  • People who experienced a severe immune-related side effect (grade 3 or above) during a previous immunotherapy treatment.
  • People with a known allergy to either of the study drugs (ILB-2109 or Toripalimab).
  • People who are currently pregnant or breastfeeding.
  • People whom the trial doctor considers unsuitable for participation for any other reason.

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 22 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: Jin Li, M.D., Shanghai East Hospital

Phone: 86-021-38863266

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
Innolake Biopharm
Registry
ClinicalTrials.gov
Start date
25 July 2023
Est. completion
25 January 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The Incidence of DLTs; MTD; RP2D; The 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: 22 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