Clinical trial NCT06885281: A 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Lead sponsor: Zai Lab (Hong Kong), Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Zai Lab (US) LLC
First posted: 2025-03-20
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse-Events in Phase Ib
timeFrame: up to 24 months
measure: Incidence of Serious Adverse Events in Phase Ib
timeFrame: up to 24 months
measure: Evaluate antitumor activity of ZL-1310 as a single agent in Phase II
timeFrame: up to 24 months
Secondary outcomes:
measure: Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase Ib
timeFrame: up to 24 months
measure: Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase II
timeFrame: up to 24 months
measure: Incidence of Treatment Emergent Adverse-Events in Phase II
timeFrame: up to 24 months
measure: Incidence of Serious Adverse Events in Phase II
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): Time to maximum concentration (Tmax) of Total Antibody in all phases
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): maximum concentration (Cmax) of Total Antibody in all phases
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Total Antibody in all phases
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): apparent clearance (CL) of Total Antibody in all phases
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): terminal elimination half-life (T1/2) of Total Antibody in all phases
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): time to maximum concentration (Tmax) of Unconjugated payloads in all phases
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): maximum concentration (Cmax) of Unconjugated payloads in all phases
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Unconjugated payloads in all phases
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): apparent clearance (CL) of Unconjugated payloads in all phases
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): terminal elimination half-life (T1/2) of unconjugated payloads in all phases
timeFrame: up to 24 months
measure: Assess immunogenicity of ZL-1310 in all phases
timeFrame: up to 24 months
measure: Evaluate stability and control of disease in all phases
timeFrame: up to 24 months
measure: Evaluate durability of response in all phases
timeFrame: up to 24 months
measure: Evaluate progression-free survival (PFS) in all phases
timeFrame: up to 24 months
measure: Evaluate survival in all phases
timeFrame: up to 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zai Lab Site 2001
state: California
city: New York
country: United States
facility: Zai Lab Site 2002
state: New York
city: Cleveland
country: United States
facility: Zai Lab Site 2024
state: Ohio
city: Philadelphia
country: United States
facility: Zai Lab Site 2004
state: Pennsylvania
city: Fairfax
country: United States
facility: Zai Lab Site 2006
state: Virginia
city: Beijing
country: China
facility: Zai Lab Site 1002
state: Beijing
city: Beijing
country: China
facility: Zai Lab Site 1013
state: Beijing
city: Guangzhou
country: China
facility: Zai Lab Site 1004
state: Guangdong
city: Shanghai
country: China
facility: Zai Lab Site 1001
state: Shanghai
Study officials:
References: