A Study of FZ-AD004 in Patients With Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

About this trial

This study is one single group of participants with advanced solid tumors. It is the first time the drug has been used in humans. There will be two parts including Dose Escalation and Dose Expansion to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FZ-AD004.

Eligibility criteria

Qualifiers

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.

Have measurable lesions defined in RECIST v. 1.1;

Disqualifiers

Have had other malignant tumors in the past 5 years;

Have CNS (central nervous system) metastasis with clinical symptoms;

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;

Trial design

Treatments tested in this trial

  • FZ-AD004

Treatment groups

121 Participants
are divided into 1 treatment group