NCT06424665 A Study of FZ-AD005 in Patients With Advanced Solid Tumors
| NCT ID | NCT06424665 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. |
| Condition | Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2024-07-03 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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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 162 participants in total. It began in 2024-07-03 with a primary completion date of 2026-08-01.
⚠ 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 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.
Eligibility Criteria
Inclusion Criteria: 1. Patients able to give written informed consent; 2. Age ≥ 18 and ≤ 75 years old, male or female; 3. Patients have histological or cytological diagnosis with advanced solid tumors ( especially SCLC or LCNEC); 4. Willingness to provide tumor tissue for testing ; 5. Have measurable lesions defined in RECIST v. 1.1; 6. Expected survival ≥ 3 months; 7. Eastern Cancer Cooperative Group (ECOG) performance status 0-1; 8. Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment. Exclusion Criteria: 1. Patients who have had previous treatment with any anti-DLL3 antibody； 2. Have had other malignant tumors in the past 5 years; 3. Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose; 4. Have active CNS (central nervous system) metastasis； 5. Had undergone major surgery or severe trauma within 4 weeks prior to the first dose; 6. Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment; 7. Patients have psychiatric history; 8. Female patients who are breastfeeding or pregnant; 9. Other reasons that researchers believe are inappropriate to participate in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06424665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma). 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 NCT06424665 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 NCT06424665 currently recruiting?
Yes, NCT06424665 is actively recruiting participants. Contact the research team at mlzhou@fd-zj.com for enrollment information.
Where is the NCT06424665 trial being conducted?
This trial is being conducted at Changsha, China, Shanghai, China, Hangzhou, China.
Who is sponsoring the NCT06424665 clinical trial?
NCT06424665 is sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.. The trial plans to enroll 162 participants.
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