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NCT06003231

NCT06003231
Active, Not Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with one of the following cancers (confirmed by a lab/biopsy): head and neck cancer (from the mouth, salivary glands, voice box, or throat — but NOT the nasopharynx), non-small cell lung cancer, ovarian/fallopian tube/peritoneal cancer, or uterine (endometrial) cancer.
  • Your cancer cannot be removed by surgery and has either spread to other parts of the body or come back locally in a way that cannot be operated on.
  • Your cancer has gotten worse after receiving platinum-based chemotherapy (the specific requirements vary depending on which cancer type you have — confirm details with trial site).
  • For lung cancer: you must also have previously received a specific type of immunotherapy (anti-PD(L)1), unless your doctor determined it was not suitable for you.
  • For lung cancer: if you have certain known gene changes (called AGAs), you must have already received a targeted treatment for those changes, if one was available.
  • For lung cancer: you must not have had more than 2 previous chemotherapy treatments for advanced disease.
  • For ovarian cancer: your cancer must have come back within 6 months or less of finishing platinum-based chemotherapy (known as "platinum-resistant").
  • For ovarian cancer: you must not have had more than 4 previous chemotherapy treatments for advanced disease.
  • For ovarian cancer: if you have a BRCA gene mutation, you must have already been treated with a type of targeted drug called a PARP inhibitor.
  • For endometrial cancer: you must not have had more than 3 previous chemotherapy treatments for advanced disease.
  • Your tumor must show a certain level of a protein called HER2 (scored 1+, 2+, or 3+) on a tissue test, OR you have a HER2 gene mutation (confirm with trial site).
  • Your cancer must be measurable on a scan using standard criteria (confirm with trial site).
  • You must be able to provide a stored or freshly prepared tumor tissue sample.
  • You must be generally well enough to carry out light daily activities — scored 0 or 1 on a standard health scale called the ECOG scale (confirm with trial site).

Who may not be able to join:

  • You have previously been treated with a drug containing a substance called MMAE (confirm with trial site).
  • You have a known allergy or sensitivity to any ingredient in the study drug, disitamab vedotin (confirm with trial site).
  • You have been diagnosed with another serious (invasive) cancer within the past 2 years, or still have signs of a previous cancer.
  • You have cancer that has spread to the brain or the lining of the brain/spinal cord, and it is currently active and has not been treated.

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 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.

Trial details

Status
Active, Not Recruiting
Phase
Phase 2
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Registry
clinicaltrials_gov
Start date
14 November 2023
Est. completion
27 March 2026

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇮🇹 Italy 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment

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