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

Zai Lab

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Solid Tumors

Treatments

Drug: ZL-1310

Study type

Interventional

Funder types

Industry

Identifiers

NCT06885281

ZL-1310-002

Details and patient eligibility

About

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

Full description

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

Enrollment

86 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion 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

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 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