RecruitingPhase 1NCT06424665

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


Sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Enrollment

162 participants

Start Date

Jul 3, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called FZ-AD005 in people with advanced solid tumors, particularly small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC). The goal is to assess the drug's safety and find the best dose. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with an advanced solid tumor — especially SCLC or LCNEC - You have measurable tumors on scans - You are in good overall health (ECOG 0–1) - You have a life expectancy of at least 3 months - You can provide a tumor tissue sample **You may NOT be eligible if...** - You have previously received any anti-DLL3 antibody treatment - You have had another cancer in the past 5 years - You have active brain metastases (cancer that has spread to the brain) - You are pregnant or breastfeeding - You have had major surgery or high-dose steroids recently - You have a significant psychiatric history Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFZ-AD005

Every 21 days for 1 cycle. Subjects will receive an intravenous infusion of FZ-AD005 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.


Locations(3)

Hunan Cancer Hospital

Changsha, Hunan, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06424665