Ireland
--:--IST
Recruiting Phase 1/2

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

NCT06885281 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2025-05-12
Last updated
2026-08-21

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

ZL-1310 →

ZL-1310: drug ZL-1310

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of Treatment Emergent Adverse-Events in Phase 1b — up to 36 months
    Number of subjects with treatment-emergent adverse events (TEAEs)
  • Incidence of Serious Adverse Events in Phase 1b — up to 36 months
    Number of subjects with serious adverse events (SAEs)
  • Evaluate antitumor activity of ZL-1310 as a single agent in Phase 2 — up to 36 months
    Confirmed objective response rate (ORR) determined by blinded independent central review (BICR) in Phase 2

Trial sites (23)

FacilityCityRegionStatus
University of California San Francisco/Helen Diller Family Comprehensive Cancer Center San Francisco California Recruiting
OSF St. Francis Medical Center Peoria Illinois Recruiting
Karmanos Cancer Center Detroit Michigan Recruiting
Memorial Sloan-Kettering Cancer Center New York New York Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania Recruiting
SCRI OP (Oncology Partners) Nashville Tennessee Recruiting
Texas Oncology / Sammons Cancer Center Dallas Texas Recruiting
The University of Texas M. D. Anderson Cancer Center Houston Texas Recruiting
Texas Oncology - Central South McAllen Texas Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
Virginia Oncology Associates Norfolk Virginia Recruiting
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
Beijing Gobroad Hospital Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Jilin Cancer Hospital Changchun Jilin Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Huashan Hospital Fudan University Shanghai Shanghai Municipality Recruiting
Shanghai Pulmonary Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06885281 on ClinicalTrials.gov ↗ ← All trials in China