Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)
Conditions
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.
Interventions
DRUGFZ-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.
Sponsors
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The dose limiting toxicity ( DLT) | 21 Days (first cycle) | To determine the dose limiting toxicities (DLTs) of FZ-AD005 |
| Maximum Tolerable Dose (MTD) | 21 Days (first cycle) | To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD. |
| Adverse Events (AEs） | Screening up to study completion, assessed up to 60 months | To check the numbers of AEs happened during the course of trial. |
| Objective Response Rate (ORR) | Up to 60 months | To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] of FZ-AD005 according to RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) | Up to 60 months | Progression-free survival (PFS) was defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first. |
| Duration of Response(DOR) | Up to 60 months | Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). |
| Overall Survival (OS) | Up to 60 months | overall survival was defined as the time from the date of the first dose start date to the date of death due to any cause. |
| Anti Drug Antibody (ADA) | Up to 36 months | To check the" Anti Drug Antibody" develops in participants against the FZ-AD005 through blood sample |
| Time to peak (Tmax) | Up to 18 weeks | To measure the time to reach the maximum contraction of Total Antibody, Free DXd and FZ-AD005 in study participants |
| Terminal elimination half-life (t1/2) | Up to 18 weeks | To measure the time of Total Antibody, Free DXd and FZ-AD005 will take to eliminate half of it's concentration from participants. |
| Maximum observed plasma concentration (Cmax) | Up to 18 weeks | To measure the maximum concentration participants obtained of Total Antibody, Free DXd and FZ-AD004 in their blood plasma. |
| Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity | Up to 18 weeks | To measure the drug profile for absorption, distribution, metabolism and excretion for Total Antibody, Free DXd and FZ-AD005 in participants blood plasma |
| Time to Cmax (Tmax) | Up to 18 weeks | To measure the time to reach the maximum contraction of Total Antibody, Free DXd and FZ-AD005 in study participants |
Countries
China
Contacts
CONTACTMengli Zhou
Outcome results
None listed