Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Biological: ZGGS18 for Injection; Biological: ZG005 for Injection

• Registration Number: NCT06938880
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Study Start: 2025-05
• Primary Completion: 2027-05
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• Medical history, CT scan, or MRI indicates the presence of CNS metastases.
• Other malignancies within 5 years.
• Any other reason deeming the participant unsuitable for the study, as judged by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1 Dose Escalation	ZGGS18 for Injection	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
Phase 1 Dose Escalation	ZG005 for Injection	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
Phase 2 Dose Expansion	ZGGS18 for Injection	ZG005 will be given RP2D every three weeks and ZGGS18 will be given 10 mg/kg every three weeks
Phase 2 Dose Expansion	ZG005 for Injection	ZG005 will be given RP2D every three weeks and ZGGS18 will be given 10 mg/kg every three weeks

Primary Outcome Measures

Name	Time	Method
Dose limited toxicity(DLT)	up to 21 days	Incidence and severity of DLT events
Adverse Event (AE)	Up to 2 years	Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.
Maximum tolerated dose(MTD)	Up to 1 years
Recommended phase II dose(RP2D)	Up to 1 years

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	Up to 2 years	Incidence of antidrug antibodies (ADA)
Objective response rate (ORR)	Up to 2 years	Objective Response Rate as Assessed by Investigator according to RECIST v1.1

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China