Clinical Trials in China / NCT06885281
Recruiting
Phase 1/2
A Study of ZL-1310 in Participants With Selected Solid Tumors
NCT06885281 · tracked via the Priya Life Science China tracker
Condition(s) studied
Solid Tumors
Study summary
A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
Eligibility
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)
* 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)or had received topoisomerase I inhibitor (e.g., irinotecan) as the immediate prior therapy that the participant had progressed from.
* 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
Primary outcome measure(s)
- Incidence of Treatment Emergent Adverse-Events in Phase 1b — up to 36 months
Number of subjects with treatment-emergent adverse events (TEAEs) - Incidence of Serious Adverse Events in Phase 1b — up to 36 months
Number of subjects with serious adverse events (SAEs) - Evaluate antitumor activity of ZL-1310 as a single agent in Phase 2 — up to 36 months
Confirmed objective response rate (ORR) determined by blinded independent central review (BICR) in Phase 2
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California San Francisco/Helen Diller Family Comprehensive Cancer Center | San Francisco | California | Recruiting |
| OSF St. Francis Medical Center | Peoria | Illinois | Recruiting |
| Karmanos Cancer Center | Detroit | Michigan | Recruiting |
| Memorial Sloan-Kettering Cancer Center | New York | New York | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| SCRI OP (Oncology Partners) | Nashville | Tennessee | Recruiting |
| Texas Oncology / Sammons Cancer Center | Dallas | Texas | Recruiting |
| The University of Texas M. D. Anderson Cancer Center | Houston | Texas | Recruiting |
| Texas Oncology - Central South | McAllen | Texas | Recruiting |
| Virginia Cancer Specialists | Fairfax | Virginia | Recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | Recruiting |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | Recruiting |
| Beijing Gobroad Hospital | Beijing | Beijing Municipality | Recruiting |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | Recruiting |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | Recruiting |
| Hunan Cancer Hospital | Changsha | Hunan | Recruiting |
| Jilin Cancer Hospital | Changchun | Jilin | Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | Recruiting |
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | Recruiting |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | Recruiting |
More Zai Lab (Shanghai) Co., Ltd. trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06885281 on ClinicalTrials.gov ↗ ← All trials in China