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Trial Title:
Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.
NCT ID:
NCT06372626
Condition:
Neuroendocrine Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Neuroendocrine
Etoposide
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Biological
Intervention name:
ZG005
Description:
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.
Arm group label:
Part 1: Dose Escalation
Arm group label:
Part 2: Dose Expansion
Intervention type:
Drug
Intervention name:
Etoposide
Description:
IV infusion
Arm group label:
Part 1: Dose Escalation
Arm group label:
Part 2: Dose Expansion
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
IV infusion
Arm group label:
Part 1: Dose Escalation
Arm group label:
Part 2: Dose Expansion
Intervention type:
Drug
Intervention name:
Placebo
Description:
0.9% Sodium Chloride Injection
Arm group label:
Part 2: Dose Expansion
Summary:
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General Hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianming Xu
Start date:
May 30, 2024
Completion date:
August 2026
Lead sponsor:
Agency:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Agency class:
Industry
Source:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06372626
