Evaluating FZ-AD005 for patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing FZ-AD004 in patients with advanced solid tumors

  This study is testing a new drug called FZ-AD004 to see if it is safe and effective for people with advanced solid tumors.

  Recruiting at 3 sites Phase 1 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Hangzhou and 2 other locations · NCT05914545

• Evaluating Light Dose for Treating Port-Wine Birthmarks with Hemoporfin PDT

  This study is testing how well a new light treatment using Hemoporfin can help people with port-wine birthmarks on their face and neck.

  Recruiting at 5 sites Phase 2 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Irvine, California and 4 other locations · NCT05171894

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.