A Study of FZ-AD005 in Patients With Advanced Solid Tumors
NCT ID: NCT06424665
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
162 participants
INTERVENTIONAL
2024-07-03
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FZ-AD005
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Hunan Cancer Hospital
Changsha, Hunan, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Lin Wu
Role: primary
Caicun Zhou
Role: primary
Zhengbo Song
Role: primary
Other Identifiers
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F0041-101
Identifier Type: -
Identifier Source: org_study_id
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