Evaluating FZ-AD005 for patients with advanced solid tumors
A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD005 in Patients With Advanced Solid Tumors
This study is testing a new treatment called FZ-AD005 to see if it can help people with advanced solid tumors like small cell lung cancer and large cell neuroendocrine carcinoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 3 sites (Changsha, Hunan and 2 other locations) |
| Trial ID | NCT06424665 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, open-label Phase I study designed to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of FZ-AD005 in patients diagnosed with advanced solid tumors, particularly small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC). Participants will be required to provide tumor tissue samples for testing and must have measurable lesions as defined by RECIST criteria. The study aims to determine the potential effectiveness of FZ-AD005 in treating these challenging cancer types.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with advanced solid tumors, specifically SCLC or LCNEC, who can provide informed consent and have measurable lesions.
Not a fit: Patients with active CNS metastasis or those who have previously received treatment with anti-DLL3 antibodies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors, potentially improving their outcomes.
How similar studies have performed: While this approach is novel in the context of FZ-AD005, similar studies targeting advanced solid tumors have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changsha, Hunan and 2 other locations
- Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Mengli Zhou
- Email: mlzhou@fd-zj.com
- Phone: 00-86-021-58953355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.