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NCT06424665RecruitingPhase 1

A Study of FZ-AD005 in Patients With Advanced Solid Tumors

A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD005 in Patients With Advanced Solid Tumors

Source: ClinicalTrials.gov · Last updated 4 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
162 (estimated)
First submitted
12 May 2024
Start date
3 Jul 2024
Primary completion date
1 Aug 2026
Lead sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
NCT number
NCT06424665

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 162
  • From 3 Jul 2024 to the primary completion date, 1 Aug 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have had previous treatment with any anti-DLL3 antibody;
  • Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;
  • 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;

Other illness

  • Have had other malignant tumors in the past 5 years;
  • Patients have psychiatric history;

Other

  • Have active CNS (central nervous system) metastasis;
  • Female patients who are breastfeeding or pregnant;
  • Other reasons that researchers believe are inappropriate to participate in this study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hunan Cancer Hospital
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting
Zhejiang Cancer Hospital
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Shanghai East Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.