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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Dose Escalation | Experimental | 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 | Experimental | ZG005 will be given RP2D every three weeks and ZGGS18 will be given 10 mg/kg every three weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZGGS18 for Injection | Biological | Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limited toxicity(DLT) | Incidence and severity of DLT events | up to 21 days |
| Adverse Event (AE) | Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations. | Up to 2 years |
| Maximum tolerated dose(MTD) | Up to 1 years | |
| Recommended phase II dose(RP2D) | Up to 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective Response Rate as Assessed by Investigator according to RECIST v1.1 | Up to 2 years |
| Immunogenicity | Incidence of antidrug antibodies (ADA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siqi Jia | Contact | +86-0512-57018310 | jiasy@zelgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| ZG005 for Injection | Biological | Intravenous infusion |
|
|
| Up to 2 years |