A Study of ZL-1310 in Participants With Selected Solid Tumors

Open to people ages 18 years and up

• 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