A Study of ZL-1310 in Participants With Selected Solid Tumors
Trial Status: active
A Phase Ib/II, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
Inclusion 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
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)
- 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
Additional locations may be listed on ClinicalTrials.gov for NCT06885281.
Locations matching your search criteria
United States
California
San Francisco
University of California San Francisco
Status: Active
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not AvailableOhio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not AvailableThis is an open-label, multiple-center, phase Ib/II study of ZL-1310 in selected solid
tumors.
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationZai Lab (Shanghai) Co., Ltd.
- Primary IDZL-1310-002
- Secondary IDsNCI-2025-02452
- ClinicalTrials.gov IDNCT06885281