Clinical trial · Interventional
A Study of 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
NCT05914545CI-TRIAL-00124514recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced and Metastatic Solid Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FZ-AD004 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: FZ-AD004
- description
- Participants enrolled in the dose escalation part or dose expansion part
- interventionNames
- Drug: FZ-AD004
Primary outcomes (4)
- measure
- The dose limiting toxicity ( DLT)
- timeFrame
- 21 Days (first cycle)
- description
- To determine the dose limiting toxicities (DLTs) of FZ-AD004.
- measure
- Maximum Tolerable Dose (MTD)
- timeFrame
- 21 Days (first cycle)
- description
- To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.