Testing FZ-AD004 in patients with advanced solid tumors
A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 121 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05914545 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, Phase 1 clinical trial evaluating the safety and efficacy of FZ-AD004 in patients with advanced or metastatic solid tumors. The study consists of two parts: a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to further assess the drug's effects. Participants will receive FZ-AD004 via intravenous infusion, and the study will monitor pharmacokinetics and clinical activity. The trial aims to provide insights into the drug's tolerability and potential therapeutic benefits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a histological or cytological diagnosis of advanced solid tumors and measurable lesions.
Not a fit: Patients with central nervous system metastasis, recent major surgery, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors.
How similar studies have performed: While this is a first-in-human trial for FZ-AD004, similar studies of novel therapies in 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. 4. Have measurable lesions defined in RECIST v. 1.1; 5. Expected survival ≥ 12 weeks; 6. Eastern Cancer Cooperative Group (ECOG) performance status 0-1; 7. 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. Have had other malignant tumors in the past 5 years; 2. Have CNS (central nervous system) metastasis with clinical symptoms; 3. Had undergone major surgery or severe trauma within 4 weeks prior to the first dose; 4. Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment; 5. Have history of psychotropic drug abuse, alcohol or drug abuse； 6. Women who are pregnant or lactating； 7. Other circumstances that is deemed not appropriate for the study.
Where this trial is running
Shanghai
- Shanghai Chest Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Xuejing Cheng
- Email: xjcheng@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.