RecruitingPhase 1Phase 2NCT06885281

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

A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors


Sponsor

Zai Lab (Shanghai) Co., Ltd.

Enrollment

112 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Signed informed consent
  • Adult men and women ≥18 years of age
  • Participants must have histologically confirmed, locally advanced or metastatic NeuroEndocrine Carcionomas (NEC), 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 Criteria14

  • 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 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

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Interventions

DRUGZL-1310

drug ZL-1310


Locations(20)

Zai Lab Site 2001

San Francisco, California, United States

Zai Lab Site 2013

Detroit, Michigan, United States

Zai Lab Site 2002

New York, New York, United States

Zai Lab Site 2024

Cleveland, Ohio, United States

Zai Lab Site 2004

Philadelphia, Pennsylvania, United States

Zai Lab Site 2014

Nashville, Tennessee, United States

Zai Lab Site 2003

Dallas, Texas, United States

Zai Lab Site 2007

Houston, Texas, United States

Zai Lab Site 2011

McAllen, Texas, United States

Zai Lab Site 2006

Fairfax, Virginia, United States

Zai Lab Site 2012

Norfolk, Virginia, United States

Zai Lab Site 1002

Beijing, Beijing Municipality, China

Zai Lab Site 1013

Beijing, Beijing Municipality, China

Zai Lab Site 1009

Xiamen, Fujian, China

Zai Lab Site 1016

Guangzhou, Guangdong, China

Zai Lab Site 1004

Guangzhou, Guangdong, China

Zai Lab Site 1012

Harbin, Heilongjiang, China

Zai Lab Site 1006

Changsha, Hunan, China

Zai Lab Site 1008

Changchun, Jilin, China

Zai Lab Site 1001

Shanghai, Shanghai Municipality, China

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NCT06885281


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