A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors, Including Cervical Cancer, Hepatocellular Carcinoma, Neuroendocrine Tumors, and Lung Cancer
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This trial is designed to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of the combination of ZGGS18 and ZG005 in patients with advanced solid tumors, including advanced cervical cancer, hepatocellular carcinoma, neuroendocrine cancer, and lung cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Fully understand this study and voluntarily sign the ICF.
• Age 18-75 years, no gender restriction.
• Patients with advanced solid tumors who have failed standard treatment or are intolerant to standard treatment, as confirmed by histopathology or cytology.
Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Siqi Jia
jiasy@zelgen.com
+86-0512-57018310
Time Frame
Start Date: 2025-05-20
Estimated Completion Date: 2028-04
Participants
Target number of participants: 60
Treatments
Experimental: Phase 1 Dose Escalation
ZG005 will be given 10mg/kg or 20mg/kg or other dose every three weeks and ZGGS18 will be given 10 mg/kg every three weeks
Experimental: Phase 2 Dose Expansion
ZG005 will be given RP2D every three weeks and ZGGS18 will be given 10 mg/kg every three weeks
Related Therapeutic Areas
Sponsors
Leads: Suzhou Zelgen Biopharmaceuticals Co.,Ltd