NCT05914545 A Study of FZ-AD004 in Patients With Advanced Solid Tumors
| NCT ID | NCT05914545 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. |
| Condition | Advanced and Metastatic Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 121 participants |
| Start Date | 2023-06-12 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 121 participants in total. It began in 2023-06-12 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05914545 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced and Metastatic Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05914545 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05914545 currently recruiting?
Yes, NCT05914545 is actively recruiting participants. Contact the research team at xjcheng@fd-zj.com for enrollment information.
Where is the NCT05914545 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05914545 clinical trial?
NCT05914545 is sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.. The trial plans to enroll 121 participants.