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

A Phase Ib/II, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors


IDENTIFIER (ClinicalTrials.gov): NCT06885281


DRUG/TREATMENT: ZL-1310


PHASE: 1/2


STATUS: Recruiting


SPONSOR: Zai Lab (Shanghai) Co., Ltd.





DESCRIPTION:


This is an open-label, multi-center Phase Ib/II study testing a new targeted treatment called ZL-1310 in selected solid tumors, including gastrointestinal and pancreatic poorly differentiated neuroendocrine carcinomas (GEP NECs) and other high-grade neuroendocrine carcinomas.


What is ZL-1310?


ZL-1310 is a novel antibody-drug conjugate (ADC) designed to target a protein called DLL3, which is commonly found on the surface of many neuroendocrine cancers. DLL3 is considered a new and promising treatment target, especially in GEP NECs.


ADCs work by combining:

  • an antibody, which seeks out cancer cells with a specific marker (like DLL3), and

  • a drug payload, often a chemotherapy molecule, that is delivered directly to those cells.


About This Study (NCT06885281)


This trial is now enrolling patients to evaluate:

  • Safety and side effects of ZL-1310

  • How well the drug works in DLL3-positive neuroendocrine carcinomas

  • How the drug behaves in the body

  • Optimal dose levels for future studies


Who Can Join (Key Inclusion Criteria)


This study includes two main groups of patients:


Cohort 1:

  • People with advanced GEP NECs (including cancers of the esophagus, stomach, pancreas, gallbladder/hepatobiliary system, or colon/rectum)

  • Must have received 1–2 prior chemotherapy or other treatment regimens


Cohort 2:

  • People with other advanced NECs or solid tumors that express DLL3

  • Must have received 1–2 prior treatment regimens


Additional notes for patients:

  • DLL3 testing is not required before enrolling for GEP NECs or other NECs

  • Previous treatment with other DLL3-targeted therapies is allowed


For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to  view this trial here.


CONTACT: 


ZaiLab_1310-002_StudyTeam

EMAIL: Zailab_1310-002_StudyTeam@zailaboratory.com

PHONE: 86 021-61632588


This is a multicenter trial with various locations. Go to the “Contacts and Locations” section of this trial page at ClinicalTrials.gov for site-specific contact information. 



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