A Study of ZL-1310 in Participants With Selected Solid Tumors
a study on Solid Tumor
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startedstudy ends around
Description
Summary
A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
Official Title
A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
Details
This is an open-label, multiple-center, phase 1b/2 study of ZL-1310 in selected solid tumors. ZL-1310 will be administered intravenously at 1.6 mg/kg every 21 days. Primary objectives include safety evaluation and confirmed objective response rate by blinded independent central review
Keywords
Solid Tumors
Eligibility
You can join if…
Open to people ages 18 years and up
- 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
You CAN'T join if...
- 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
Locations
- Zai Lab Site 2001
accepting new patients
San Francisco California 94143 United States - Zai Lab Site 2003
accepting new patients
Dallas Texas 75246 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
- ID
- NCT06885281
- Phase
- Phase 1/2 Solid Tumor Research Study
- Study Type
- Interventional
- Participants
- Expecting 166 study participants
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Providing your contact details does not obligate you to participate in the research.
Thank you!
The study team should get back to you in a few business days.