RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-05-12

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06885281

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Signed informed consent * Adult men and women ≥18 years of age * Participants must have histologically confirmed, locally advanced or metastatic NECs, 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	* 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 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

Inclusion Criteria

Exclusion Criteria

* Signed informed consent
* Adult men and women ≥18 years of age
* Participants must have histologically confirmed, locally advanced or metastatic NECs, 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

* 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 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

Contacts and Locations

Study Contact

Shanshan Xu

CONTACT

86 15102230909

shanshan.xu@zailaboratory.com

Herman Liu

CONTACT

8579713465

herman.liu@zailaboratory.com

Study Locations (Sites)

Zai Lab Site 2001

San Francisco, California, 94143

United States

Zai Lab Site 2002

New York, New York, 10065

United States

Zai Lab Site 2024

Cleveland, Ohio, 44106

United States

Zai Lab Site 2004

Philadelphia, Pennsylvania, 19111

United States

Zai Lab Site 2006

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-12

Study Completion Date2027-06

Study Record Updates

Study Start Date2025-05-12

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Solid Tumors