Clinical trial NCT05914545: A Study of FZ-AD004 in Patients with Advanced Solid Tumors
Official title: A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD004 in Patients with Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced and Metastatic Solid Tumor
Keywords: Advanced and Metastatic Solid Tumor
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a first-in-human (FIH), Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of FZ-AD004 in patients with advanced/metastatic solid tumors. FZ-AD004 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD) and dose-limiting toxicities（DLT）during cycle 1. In addition, the maximum-tolerated dose and recommended Phase II dose for FZ-AD004 will be determined.

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.
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.

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
timeFrame: Screening up to study completion
measure: Objective Response Rate (ORR) according to RECIST 1.1
timeFrame: From subject randomization up to 60 months.
Secondary outcomes:
measure: Progression free survival(PFS) according to RECIST 1.1
timeFrame: From subject randomization up to 60 months.
measure: Duration of Response(DOR) according to RECIST 1.1
timeFrame: From subject randomization up to 60 months
measure: Overall Survival (OS) according to RECIST 1.1
timeFrame: From subject randomization up to 60 months.
measure: Terminal elimination half-life (t1/2) of Total Antibody, Free DXd and FZ-AD004
timeFrame: Up to 17 weeks
measure: Maximum observed plasma concentration (Cmax) of Total Antibody, Free DXd and FZ-AD004
timeFrame: Up to 17 weeks
measure: Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of Total Antibody, Free DXd and FZ-AD004
timeFrame: Up to 17 weeks
measure: Time to Cmax (Tmax) of Total Antibody, Free DXd and FZ-AD004
timeFrame: Up to 17 weeks
measure: Number of subjects who develop detectable anti-drug antibodies (ADAs)
timeFrame: From subject randomization up to 60 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References: