A Study of FZ-AD005 in Patients With Advanced Solid Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06424665
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)
Arms & Interventions

Arms

Experimental: FZ-AD005

Interventions

Drug: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hunan Cancer Hospital, Changsha, Hunan, China

Status

Address

Hunan Cancer Hospital

Changsha, Hunan, 410013

Shanghai East Hospital, Shanghai, Shanghai, China

Status

Address

Shanghai East Hospital

Shanghai, Shanghai, 200120

Site Contact

Caicun Zhou

[email protected]

00-86-021-58953355

Shanghai Pulmonary Hospital, Shanghai, Shanghai, China

Status

Address

Shanghai Pulmonary Hospital

Shanghai, Shanghai, 200120

Site Contact

Shengxiang Ren

[email protected]

00-86-021-58953355

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

Status

Address

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022

Site Contact

Zhengbo Song

[email protected]

00-86-021-58953355

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