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

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: ZL-1310

Detailed Description

This is an open-label, multiple-center, phase 1b/2 study of ZL-1310 in selected solid tumors.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: ZaiLab_1310-002_StudyTeam; Phone Number: 86 021-61632588; Email: Zailab_1310-002_StudyTeam@zailaboratory.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Zai Lab Site 1002
      • Contact: Site 1002
    • Beijing, Beijing Municipality, China, 102200
      • Recruiting
      • Zai Lab Site 1013
      • Contact: Site 1013
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • Zai Lab Site 1009
      • Contact: Site 1009
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Zai Lab Site 1004
      • Contact: Site 1004
    • Guangzhou, Guangdong, China, 510030
      • Recruiting
      • Zai Lab Site 1016
      • Contact: Site 1016
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Recruiting
      • Zai Lab Site 1012
      • Contact: Site 1012
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Zai Lab Site 1006
      • Contact: Site 1006
  • Jilin
    • Changchun, Jilin, China, 130012
      • Recruiting
      • Zai Lab Site 1008
      • Contact: Site 1008
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Recruiting
      • Zai Lab Site 1001
      • Contact: Site 1001
• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • Zai Lab Site 2001
      • Contact: Site 2001
  • Illinois
    • Peoria, Illinois, United States, 61637
      • Recruiting
      • Zai Lab Site 2015
      • Contact: Site 2015
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Zai Lab Site 2013
      • Contact: Site 2013
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Zai Lab Site 2002
      • Contact: Site 2002
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Zai Lab Site 2024
      • Contact: Site 2024
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Recruiting
      • Zai Lab Site 2004
      • Contact: Site 2004
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Zai Lab Site 2014
      • Contact: Site 2014
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Zai Lab Site 2003
      • Contact: Site 2003
    • Houston, Texas, United States, 77030
      • Recruiting
      • Zai Lab Site 2007
      • Contact: Site 2007
    • McAllen, Texas, United States, 78503
      • Recruiting
      • Zai Lab Site 2011
      • Contact: Site 2011
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Zai Lab Site 2006
      • Contact: Site 2006
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Zai Lab Site 2012
      • Contact: Site 2012

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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), 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 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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; ZL-1310 as a single agent	Drug: ZL-1310; drug ZL-1310

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse-Events in Phase 1b	Number of subjects with treatment-emergent adverse events (TEAEs)	up to 31 months
Incidence of Serious Adverse Events in Phase 1b	Number of subjects with serious adverse events (SAEs)	up to 31 months
Evaluate antitumor activity of ZL-1310 as a single agent in Phase 2	Confirmed objective response rate (ORR) determined by blinded independent central review (BICR) in Phase 2	up to 31 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 1b	BICR-determined confirmed ORR in Phase 1b; Investigator-determined confirmed ORR in Phase 1b	up to 31 months
Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 2	Investigator-determined confirmed ORR in Phase 2	up to 31 months
Incidence of Treatment Emergent Adverse-Events in Phase 2	Number of subjects with treatment-emergent adverse events (TEAEs)	up to 31 months
Incidence of Serious Adverse Events in Phase 2	Number of subjects with serious adverse events (SAEs)	up to 31 months
Pharmacokinetics (PK): Time to maximum concentration (Tmax) of Total Antibody in all phases	Time to maximum concentration (Tmax) is a pharmacokinetic parameter that refers to the time it takes for a drug or substance to reach its highest concentration in the bloodstream or a specific body compartment after administration	up to 31 months
Pharmacokinetics (PK): maximum concentration (Cmax) of Total Antibody in all phases	Maximum concentration (Cmax) is a key pharmacokinetic parameter. It represents the highest concentration of a drug or substance that is achieved in the bloodstream or a specific biological fluid or tissue after administration	up to 31 months
Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Total Antibody in all phases	Area under the concentration-time curve (AUC) is a pharmacokinetic parameter that quantitatively describes the total exposure of a drug in the body over a specific period of time	up to 31 months
Pharmacokinetics (PK): apparent clearance (CL) of Total Antibody in all phases	Apparent clearance (CL) is a pharmacokinetic parameter that describes the rate at which a drug is removed from the body relative to the drug's concentration in the bloodstream or a specific body fluid	up to 31 months
Pharmacokinetics (PK): terminal elimination half-life (T1/2) of Total Antibody in all phases	Terminal elimination half-life (T1/2) is a pharmacokinetic parameter that characterizes the time it takes for the concentration of a drug in the body to decrease by half during the terminal phase of drug elimination	up to 31 months
Pharmacokinetics (PK): time to maximum concentration (Tmax) of Unconjugated payloads in all phases	Time to maximum concentration (Tmax) is a pharmacokinetic parameter that refers to the time it takes for a drug or substance to reach its highest concentration in the bloodstream or a specific body compartment after administration	up to 31 months
Pharmacokinetics (PK): maximum concentration (Cmax) of Unconjugated payloads in all phases	Maximum concentration (Cmax) is a key pharmacokinetic parameter. It represents the highest concentration of a drug or substance that is achieved in the bloodstream or a specific biological fluid or tissue after administration	up to 31 months
Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Unconjugated payloads in all phases	The area under the concentration - time curve (AUC) is a pharmacokinetic parameter that quantitatively describes the total exposure of a drug in the body over a specific period of time	up to 31 months
Pharmacokinetics (PK): apparent clearance (CL) of Unconjugated payloads in all phases	Apparent clearance (CL) is a pharmacokinetic parameter that describes the rate at which a drug is removed from the body relative to the drug's concentration in the bloodstream or a specific body fluid	up to 31 months
Pharmacokinetics (PK): terminal elimination half-life (T1/2) of unconjugated payloads in all phases	Terminal elimination half - life (T1/2) is a pharmacokinetic parameter that characterizes the time it takes for the concentration of a drug in the body to decrease by half during the terminal phase of drug elimination	up to 31 months
Assess immunogenicity of ZL-1310 in all phases	Incidence of anti-drug antibodies (ADAs) to ZL-1310 in all phases	up to 31 months
Evaluate stability and control of disease in all phases	BICR- and investigator-determined disease control rate (DCR) in all phases	up to 31 months
Evaluate durability of response in all phases	BICR- and investigator-determined duration of response (DOR) in all phases	up to 31 months
Evaluate progression-free survival (PFS) in all phases	BICR- and investigator-determined PFS in all phases	up to 31 months
Evaluate survival in all phases	Overall survival (OS) in all phases	up to 31 months

Collaborators and Investigators

• Sponsor: Zai Lab (Shanghai) Co., Ltd.
• Collaborators: Zai Lab (US) LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ZL-1310-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No