Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT05555251
Eligibility Criteria:
Main Inclusion Criteria:
* Is willing and able to provide written informed consent for the trial.
* Is ≥18 years of age on day of signing informed consent.
* Has received standard of care or is intolerant to standard of care antineoplastic therapy. Subjects who are intolerant to trastuzumab cannot be enrolled in the study.
* Has at least 1 measurable disease lesion as defined by RECIST v1.1 criteria.
* Has a locally confirmed HER2+ tumor.
* Must have progressive disease after the last line of treatment. In addition, subjects must have received the following previous lines of treatment:
1. Prior lines of treatment including trastuzumab and chemotherapy.
2. At least one prior line of treatment with an antibody-drug conjugate (ADC) (eg, trastuzumab-emtansine \[TDM-1, or trastuzumab-deruxtecan\]).
Main Exclusion Criteria:
* Needs doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has cardiac or renal amyloid light-chain amyloidosis.
* Has had clinically significant lung disease requiring systemic corticosteroid treatment within the last 6 months of enrollment.
* Has an active, known, or suspected autoimmune disease.
* Is at high medical risk because of nonmalignant systemic disease including severe active infections on treatment with antibiotics, antifungals, or antivirals.
* Has presence of chronic graft versus host disease.
* Has had an allogenic tissue/solid organ transplant.
* Has uncontrolled or significant cardiovascular disease.
* Has a known additional malignancy of another type, except for adequately treated cone-biopsied carcinoma in situ (eg, breast carcinoma, cervical cancer in situ), adequately controlled superficial bladder cancer, and basal or squamous cell carcinoma of the skin.
* Has a diagnosis of primary or acquired immunodeficiency disorder or is taking any other form of immunosuppressive therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05555251
Study Brief:
Protocol Section:
NCT05555251