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Recruiting NCT06424665

A Study of FZ-AD005 in Patients With Advanced Solid Tumors

Phase I Interventional Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FZ-AD005.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD005 in Patients With Advanced Solid Tumors

Overview

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.

Interventions

  • Drug FZ-AD005
    Every 21 days for 1 cycle. Subjects will receive an intravenous infusion of FZ-AD005 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

Primary outcome measures

  • The dose limiting toxicity ( DLT) [Time frame: 21 Days (first cycle)]
  • Maximum Tolerable Dose (MTD) [Time frame: 21 Days (first cycle)]
  • Adverse Events (AEs） [Time frame: Screening up to study completion, assessed up to 60 months]
  • Objective Response Rate (ORR) [Time frame: Up to 60 months]
Secondary outcome measures (9)
  • Progression free survival(PFS) [Time frame: Up to 60 months]
  • Duration of Response(DOR) [Time frame: Up to 60 months]
  • Overall Survival (OS) [Time frame: Up to 60 months]
  • Anti Drug Antibody (ADA) [Time frame: Up to 36 months]
  • Time to peak (Tmax) [Time frame: Up to 18 weeks]
  • Terminal elimination half-life (t1/2) [Time frame: Up to 18 weeks]
  • Maximum observed plasma concentration (Cmax) [Time frame: Up to 18 weeks]
  • Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity [Time frame: Up to 18 weeks]
  • Time to Cmax (Tmax) [Time frame: Up to 18 weeks]

Eligibility criteria

Inclusion criteria

  • 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 ( especially SCLC or LCNEC);
  • Willingness to provide tumor tissue for testing ;
  • Have measurable lesions defined in RECIST v. 1.1;
  • Expected survival ≥ 3 months;
  • Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
  • 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

  • Patients who have had previous treatment with any anti-DLL3 antibody；
  • Have had other malignant tumors in the past 5 years;
  • Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;
  • Have active CNS (central nervous system) metastasis；
  • 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;
  • Patients have psychiatric history;
  • Female patients who are breastfeeding or pregnant;
  • Other reasons that researchers believe are inappropriate to participate in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Hunan Cancer Hospital — Changsha
  • Shanghai East Hospital — Shanghai
  • Zhejiang Cancer Hospital — Hangzhou

Identifiers

NCT: NCT06424665 · F0041-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗