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

Phase 1

Not yet recruiting

• Conditions: Solid Tumors
• Interventions: Drug: ZL-1310

• Registration Number: NCT06885281
• Lead Sponsor: Zai Lab (Shanghai) Co., Ltd.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2025-02-24
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-20
• Study Start: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-20
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	ZL-1310	ZL-1310 as a single agent

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse-Events in Phase Ib	up to 24 months	Number of subjects with treatment-emergent adverse events (TEAEs)
Incidence of Serious Adverse Events in Phase Ib	up to 24 months	Number of subjects with serious adverse events (SAEs)
Evaluate antitumor activity of ZL-1310 as a single agent in Phase II	up to 24 months	Confirmed objective response rate (ORR) determined by blinded independent central review (BICR) in Phase II

Secondary Outcome Measures

Name	Time	Method
Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase Ib	up to 24 months	1. BICR-determined confirmed ORR in Phase Ib; 2. Investigator-determined confirmed ORR in Phase Ib
Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase II	up to 24 months	Investigator-determined confirmed ORR in Phase II
Incidence of Treatment Emergent Adverse-Events in Phase II	up to 24 months	Number of subjects with treatment-emergent adverse events (TEAEs)
Incidence of Serious Adverse Events in Phase II	up to 24 months	Number of subjects with serious adverse events (SAEs)
Pharmacokinetics (PK): Time to maximum concentration (Tmax) of Total Antibody in all phases	up to 24 months	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
Pharmacokinetics (PK): maximum concentration (Cmax) of Total Antibody in all phases	up to 24 months	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
Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Total Antibody in all phases	up to 24 months	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
Pharmacokinetics (PK): apparent clearance (CL) of Total Antibody in all phases	up to 24 months	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
Pharmacokinetics (PK): terminal elimination half-life (T1/2) of Total Antibody in all phases	up to 24 months	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
Pharmacokinetics (PK): time to maximum concentration (Tmax) of Unconjugated payloads in all phases	up to 24 months	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
Pharmacokinetics (PK): maximum concentration (Cmax) of Unconjugated payloads in all phases	up to 24 months	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
Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Unconjugated payloads in all phases	up to 24 months	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
Pharmacokinetics (PK): apparent clearance (CL) of Unconjugated payloads in all phases	up to 24 months	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
Pharmacokinetics (PK): terminal elimination half-life (T1/2) of unconjugated payloads in all phases	up to 24 months	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
Assess immunogenicity of ZL-1310 in all phases	up to 24 months	Incidence of anti-drug antibodies (ADAs) to ZL-1310 in all phases
Evaluate stability and control of disease in all phases	up to 24 months	BICR- and investigator-determined disease control rate (DCR) in all phases
Evaluate durability of response in all phases	up to 24 months	BICR- and investigator-determined duration of response (DOR) in all phases
Evaluate progression-free survival (PFS) in all phases	up to 24 months	BICR- and investigator-determined PFS in all phases
Evaluate survival in all phases	up to 24 months	Overall survival (OS) in all phases