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NCT05317078

NCT05317078
Terminated Phase 1 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are 18 years of age or older.
  • You have a solid tumor cancer that has been confirmed by a lab test, and your tumor produces a protein called claudin-6 (CLDN6) — this may include lung cancer, ovarian cancer, testicular cancer, uterine cancer, or triple-negative breast cancer, among others.
  • Your cancer has spread to other parts of the body or cannot be removed by surgery.
  • You have already tried standard available cancer treatments, or you are not a suitable candidate for those treatments.
  • You are generally able to carry out basic daily activities with little or no limitation (your doctor can assess this).
  • Your heart, liver, kidneys, and other organs are working well enough to participate.
  • You are expected to live for more than 3 months.
  • For certain parts of the trial, a tissue sample from your tumor must be available and must show that the claudin-6 protein is present.
  • For certain expanded parts of the trial, you must have at least one measurable tumor spot of 10mm or larger that has not been biopsied in the last 3 months.
  • You have given your written agreement to take part before any study procedures begin.

Who may not be able to join:

  • You have tested positive for HIV, hepatitis B, or hepatitis C.
  • You have been diagnosed with another type of cancer within the past 2 years.
  • You currently have signs of an active, uncontrolled infection in the week before starting the study treatment.
  • You have cancer that has spread to the brain or spinal cord that is new, growing, or causing symptoms — though people with stable, previously treated brain metastases may still be eligible (confirm with trial site).
  • You are currently taking part in another clinical trial, or finished one less than 4 weeks ago.
  • You have received chemotherapy, radiation, or certain targeted cancer treatments within the past 2 weeks (or longer, depending on the specific drug), or immunotherapy within the past 3 weeks.
  • You have had major surgery within the past 4 weeks (minor procedures like biopsies do not count).
  • You have an autoimmune condition (such as Crohn's disease or ulcerative colitis) that requires ongoing steroid or immune-suppressing medication.
  • You are a woman who could become pregnant and are unwilling to use the contraception methods required by the study, or you are currently breastfeeding or planning to become pregnant.
  • You are a man with a female partner who could become pregnant, and you are unwilling to use the required contraception methods or abstain from donating sperm.
  • You have a known allergy or sensitivity to any of the study medications or their ingredients.
  • You are unlikely to be able to attend all required study visits or follow the study procedures.
  • You have another significant health condition that, in the doctor's opinion, could put you at risk or interfere with the study (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.

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.

Trial details

Status
Terminated
Phase
Phase 1
Sponsor
Amgen
Registry
clinicaltrials_gov
Start date
28 February 2023
Est. completion
19 December 2023

Where this trial is recruiting

🇦🇺 Australia 🇨🇭 Switzerland 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Participants Who Experience a Dose Limiting Toxicity (DLT); Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE); Number of Participants Who Experience a Treatment-related AE

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.

View original record on ClinicalTrials.gov