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A Study of ZL-1310 in Participants With Selected Solid Tumors
A Study of ZL-1310 in Participants With Selected Solid Tumors
RecruitingPhase 1, Phase 2
Sponsor: Zai Lab (Shanghai) Co., Ltd.
Conditions: Solid Tumors
Interventions: ZL-1310
Countries: United States, China
A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Signed informed consent * Adult men and women ≥18 years of age * Participants must have histologically confirmed, locally advanced or metastatic NeuroEndocrine Carcionomas (NEC) * 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 Exclusion Criteria: * 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)or had received topoisomerase I inhibitor (e.g., irinotecan) as the immediate prior therapy that the participant had progressed from. * 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 to non-thoracic area or within 4 weeks to the thoracic area 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
Locations (23)
- San Francisco, California, United States
- Peoria, Illinois, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- McAllen, Texas, United States
- Fairfax, Virginia, United States
- Norfolk, Virginia, United States
- Beijing, Beijing Municipality, China
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Guangzhou, Guangdong, China
- Harbin, Heilongjiang, China
- Changsha, Hunan, China
- Changchun, Jilin, China
- Shanghai, Shanghai Municipality, China
- Shanghai, Shanghai Municipality, China
- Shanghai, Shanghai Municipality, China