No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
162 (estimated)
Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for patients with advanced solid tumors, particularly small cell lung cancer or large cell neuroendocrine carcinoma. Participants will receive the drug FZ-AD005 and provide tumor tissue for testing.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I can give written consent.
I have advanced solid tumors.
I am willing to provide tumor tissue for testing.
I have measurable lesions.
I expect to live at least 3 more months.
I have a performance status of 0-1.
I will use contraception if I am able to have children.
You may not be able to join if
I have previously been treated with any anti-DLL3 antibody.
I have had other cancer in the past 5 years.
I am currently receiving other anti-tumor treatments.
I have active central nervous system metastasis.
I have had major surgery or severe trauma in the last 4 weeks.
I have used high-dose steroids in the past 2 weeks.
I have a psychiatric history.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 measurab…
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.
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