Clinical trial NCT06424665: A Study of FZ-AD005 in Patients With Advanced Solid Tumors
Official title: A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD005 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-22
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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 ( 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.

Primary outcomes:
measure: The dose limiting toxicity ( DLT)
timeFrame: 21 Days (first cycle)
measure: Maximum Tolerable Dose (MTD)
timeFrame: 21 Days (first cycle)
measure: Adverse Events (AEs）
timeFrame: Screening up to study completion, assessed up to 60 months
measure: Objective Response Rate (ORR)
timeFrame: Up to 60 months
Secondary outcomes:
measure: Progression free survival(PFS)
timeFrame: Up to 60 months
measure: Duration of Response(DOR)
timeFrame: Up to 60 months
measure: Overall Survival (OS)
timeFrame: Up to 60 months
measure: Anti Drug Antibody (ADA)
timeFrame: Up to 36 months
measure: Time to peak (Tmax)
timeFrame: Up to 18 weeks
measure: Terminal elimination half-life (t1/2)
timeFrame: Up to 18 weeks
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 18 weeks
measure: Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity
timeFrame: Up to 18 weeks
measure: Time to Cmax (Tmax)
timeFrame: Up to 18 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: