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New treatment option for Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large...
Official title A Study of FZ-AD005 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06424665
What this study is testing
What is FZ-AD005?
FZ-AD005 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor, sclc(small cell lung cancer) or lcnec (large cell neuroendocrine carcinoma).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients able to give written informed consent;
- Age ≥ 18 and ≤ 75 years old, male or female;
- Patients have histological or cytological diagnosis with advanced solid tumors ( especially SCLC or LCNEC);
- Willingness to provide tumor tissue for testing ;
- Have measurable lesions defined in RECIST v. 1.1;
You likely can't join if
- Patients who have had previous treatment with any anti-DLL3 antibody；
- Have had other malignant tumors in the past 5 years;
- Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;
- Have active CNS (central nervous system) metastasis；
- Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
- Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;
See the full eligibility criteria
- Patients able to give written informed consent;
- Age ≥ 18 and ≤ 75 years old, male or female;
- Patients have histological or cytological diagnosis with advanced solid tumors ( especially SCLC or LCNEC);
- Willingness to provide tumor tissue for testing ;
- Have measurable lesions defined in RECIST v. 1.1;
- Expected survival ≥ 3 months;
- Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
- Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.
- Patients who have had previous treatment with any anti-DLL3 antibody；
- Have had other malignant tumors in the past 5 years;
- Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;
- Have active CNS (central nervous system) metastasis；
- Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
- Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;
- Patients have psychiatric history;
- Female patients who are breastfeeding or pregnant;
- Other reasons that researchers believe are inappropriate to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China; Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.