NCT06885281 A Study of ZL-1310 in Participants With Selected Solid Tumors
| NCT ID | NCT06885281 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Zai Lab (Shanghai) Co., Ltd. |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 166 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 166 participants in total. It began in 2025-05-12 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06885281 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06885281 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06885281 currently recruiting?
Yes, NCT06885281 is actively recruiting participants. Contact the research team at Zailab_1310-002_StudyTeam@zailaboratory.com for enrollment information.
Where is the NCT06885281 trial being conducted?
This trial is being conducted at San Francisco, United States, Peoria, United States, Detroit, United States, New York, United States and 11 additional locations.
Who is sponsoring the NCT06885281 clinical trial?
NCT06885281 is sponsored by Zai Lab (Shanghai) Co., Ltd.. The trial plans to enroll 166 participants.