Study on ZL-1310 for Patients with Certain Advanced Solid Tumors
Sponsor: Zai Lab (Shanghai) Co., Ltd.
ClinicalTrials ID:NCT06885281
This clinical trial is testing a new drug, ZL-1310, to see if it is safe and effective for treating certain advanced solid tumors in adults who have not responded to previous treatments.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new drug called ZL-1310 in adults with specific types of advanced solid tumors. The study is open-label, meaning both the researchers and participants know what treatment is being given, and it is conducted at multiple centers.
Description
This clinical trial is designed to test a new treatment, ZL-1310, in adults with certain advanced solid tumors. The study is open-label, which means that both the participants and the researchers know what treatment is being administered. It is being conducted at multiple locations to gather more comprehensive data. The trial is divided into two phases: Phase Ib and Phase II, focusing on assessing the safety and effectiveness of ZL-1310 in patients whose cancer has progressed despite previous treatments.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of locally advanced or metastatic neuroendocrine carcinomas (NECs) that have worsened after platinum-based therapy.
- Be willing to undergo a tumor biopsy or provide a previous tumor sample.
- Have at least one tumor that can be measured using standard criteria.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a life expectancy of at least 3 months.
Exclusion Criteria
- Have another type of cancer that is progressing or needs treatment within the last 2 years.
- Have active cancer that has spread to the brain or spinal cord.
- Have cancer that has spread to the membranes surrounding the brain and spinal cord.
- Have received any previous treatment with a specific type of drug similar to ZL-1310.
- Have had any other cancer treatment or investigational drugs within 3 weeks before starting the study treatment.
- Have had non-palliative radiation therapy within 2 weeks before starting the study treatment or a history of lung inflammation due to radiation.
- Have had major surgery within 4 weeks before starting the study treatment.
- Have allergies to any ingredients in the study treatment.
- Have certain abnormal lab values within 10 days before starting the study treatment.
- Have significant heart problems within the last 3 months.
- Have lung-specific illnesses or autoimmune disorders, including lung inflammation.
- Have a history of lung inflammation that required steroids or current lung inflammation.
- Be pregnant or breastfeeding.
- Have been taking certain strong medications that affect liver enzymes within 14 days or 5 half-lives before starting the study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Zai Lab Site 2001 | 94143 | San Francisco | California |
| Zai Lab Site 2002 | 10065 | New York | New York |
| Zai Lab Site 2024 | 44106 | Cleveland | Ohio |
| Zai Lab Site 2004 | 19111 | Philadelphia | Pennsylvania |
| Zai Lab Site 2006 | 22031 | Fairfax | Virginia |
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