Clinical trial · Interventional
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
NCT06424665CI-TRIAL-00104570recruitingPhase 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)
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.
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 Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma) | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FZ-AD005 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FZ-AD005
- interventionNames
- Drug: FZ-AD005
Primary outcomes (4)
- measure
- The dose limiting toxicity ( DLT)
- timeFrame
- 21 Days (first cycle)
- description
- To determine the dose limiting toxicities (DLTs) of FZ-AD005
- 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.
- measure
- Adverse Events (AEs）
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 ( especially SCLC or LCNEC); 4. Willingness to provide tumor tissue for testing ; 5. Have measurable lesions defined in RECIST v. 1.1; 6. Expected survival ≥ 3 months; 7. Eastern Cancer Cooperative Group (ECOG) performance status 0-1; 8. 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. Patients who have had previous treatment with any anti-DLL3 antibody； 2. Have had other malignant tumors in the past 5 years; 3. Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose; 4. Have active CNS (central nervous system) metastasis； 5. Had undergone major surgery or severe trauma within 4 weeks prior to the first dose; 6. Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment; 7. Patients have psychiatric history; 8. Female patients who are breastfeeding or pregnant; 9. Other reasons that researchers believe are inappropriate to participate in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.