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Recruiting NCT06885281

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

Phase I / Phase II Interventional Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ZL-1310.
Who it may be relevant to
Registry conditions: Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

This is an open-label, multiple-center, phase 1b/2 study of ZL-1310 in selected solid tumors. ZL-1310 will be administered intravenously at 1.6 mg/kg every 21 days. Primary objectives include safety evaluation and confirmed objective response rate by blinded independent central review

Interventions

  • Drug ZL-1310
    drug ZL-1310

Primary outcome measures

  • Incidence of Treatment Emergent Adverse-Events in Phase 1b [Time frame: up to 36 months]
  • Incidence of Serious Adverse Events in Phase 1b [Time frame: up to 36 months]
  • Evaluate antitumor activity of ZL-1310 as a single agent in Phase 2 [Time frame: up to 36 months]
Secondary outcome measures (12)
  • Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 1b [Time frame: up to 36 months]
  • Evaluate durability of response in Phase 1b [Time frame: up to 36 months]
  • Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 2 [Time frame: up to 36 months]
  • Evaluate durability of response in Phase 2 [Time frame: up to 36 months]
  • Incidence of Treatment Emergent Adverse-Events in Phase 2 [Time frame: up to 36 months]
  • Incidence of Serious Adverse Events in Phase 2 [Time frame: up to 36 months]
  • Pharmacokinetics (PK): Time to maximum concentration (Tmax) of Total Antibody in all phases [Time frame: up to 36 months]
  • Pharmacokinetics (PK): maximum concentration (Cmax) of Total Antibody in all phases [Time frame: up to 36 months]
  • Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Total Antibody in all phases [Time frame: up to 36 months]
  • Pharmacokinetics (PK): apparent clearance (CL) of Total Antibody in all phases [Time frame: up to 36 months]
  • Pharmacokinetics (PK): terminal elimination half-life (T1/2) of Total Antibody in all phases [Time frame: up to 36 months]
  • Pharmacokinetics (PK): time to maximum concentration (Tmax) of Unconjugated payloads in all phases [Time frame: up to 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • Zai Lab Site 2001 — San Francisco
  • Zai Lab Site 2015 — Peoria
  • Zai Lab Site 2013 — Detroit
  • Zai Lab Site 2002 — New York
  • Zai Lab Site 2024 — Cleveland
  • Zai Lab Site 2004 — Philadelphia
  • Zai Lab Site 2014 — Nashville
  • Zai Lab Site 2003 — Dallas
  • … and 4 more centers
China · 11 centers
  • Zai Lab Site 1002 — Beijing
  • Zai Lab Site 1013 — Beijing
  • Zai Lab Site 1009 — Xiamen
  • Zai Lab Site 1016 — Guangzhou
  • Zai Lab Site 1004 — Guangzhou
  • Zai Lab Site 1012 — Harbin
  • Zai Lab Site 1006 — Changsha
  • Zai Lab Site 1008 — Changchun
  • … and 3 more centers

Identifiers

NCT: NCT06885281 · ZL-1310-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗