ZL-1310 for selected advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase 1b/2 study gives ZL-1310 to adults with selected advanced or metastatic solid tumors to characterize safety, tolerability, and preliminary anti-tumor activity. Participants must have measurable disease, ECOG performance status 0–1, life expectancy of at least three months, and must provide a tumor biopsy or archived tissue. Key exclusions include clinically active CNS or leptomeningeal metastases, another progressing malignancy requiring treatment within the past two years, prior treatment with antibody-drug conjugates carrying topoisomerase I payloads, and recent systemic anti-cancer therapy. The trial is run at multiple Zai Lab sites in the United States and follows a Phase 1b/2 design with dose-finding and expansion elements.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California San Francisco/Helen Diller Family Comprehensive Cancer Center
  San Francisco, California, United States Recruiting
• OSF St. Francis Medical Center
  Peoria, Illinois, United States Recruiting
• Karmanos Cancer Center
  Detroit, Michigan, United States Recruiting
• Memorial Sloan-Kettering Cancer Center
  New York, New York, United States Recruiting
• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting
• Fox Chase Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: ZaiLab_1310-002_StudyTeam
• Email: Zailab_1310-002_StudyTeam@zailaboratory.com
• Phone: 6503601601

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.