Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * Signed informed consent
- * Adult men and women ≥18 years of age
- * Participants must have histologically confirmed, locally advanced or metastatic NECs, and must have experienced disease progression on or after platinum-based therapy
- * Participants must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample
- * Participants must have at least one measurable target lesion as defined by RECIST v1.1
- * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- * Life expectancy ≥ 3 months
- * Participants with another known malignancy that is progressing or requires active treatment within the last 2 years
- * Clinically active central nervous system (CNS) metastases
- * Participants with leptomeningeal metastasis
- * Participants who have received any ADC with a payload of topoisomerase I inhibitor (e.g., exatecan derivative)
- * Treatment with any systemic anti-cancer treatment or other investigational products/device within 3 weeks before the first dose of study treatment
- * Non-palliative radiotherapy within 2 weeks prior to first dose of study treatment or a history of radiation pneumonitis
- * Major surgery within 4 weeks of the first dose of study treatment
- * Hypersensitivity to any ingredient of the study treatment
- * Out of range value (as defined in protocol) within 10 days prior to the first dose of study treatment
- * Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
- * Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders including but not limited to pneumonitis
- * Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
- * Pregnant or nursing (lactating) women
- * Participants who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No