Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.

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Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.

Study Purpose

The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment.

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 - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Fully understand the study and voluntarily sign the informed consent form.

- Male or female 18-70 years of age.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

- Histologically confirmed recurrent or metastatic neuroendocrine carcinoma.

- Life expectancy ≥ 3 months.

Exclusion Criteria:

- Medical history, computed tomography or magnetic resonance imaging results indicate that existence of the central nervous system metastases; - Any other malignancy within 5 years.

- participants were deemed unsuitable for participating in the study by the investigator for any reasons.

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.	NCT06372626
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/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jason Wu
Principal Investigator Affiliation	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Carcinoma

Arms & Interventions

Arms

Experimental: Part 1: Dose Escalation

Dose-escalation study of ZG005 in combination with Etoposide and Cisplatin.

Experimental: Part 2: Dose Expansion

Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin.

Interventions

Biological: - ZG005

ZG005 for dose escalations are set as 10mg/kg, 20mg/kg, and the other doses after discussion. intravenous infusion, once every 3 weeks. ZG005 for dose expansion will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.

Drug: - Etoposide

IV infusion

Drug: - Cisplatin

IV infusion

Drug: - Placebo

0.9% Sodium Chloride Injection

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.