Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental |
| |
| Dose Expansion | Experimental | Tumor type: colorectal cancer,pancreatic cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZGGS18 for Injection | Biological | 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kgof ZGGS18,intravenous infusion, once every 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of ZGGS18 | Dose limiting toxicity, number of participants with abnormal laboratory values and/or adverse events that are related to treatment | 28 days |
| Safety of ZGGS18 | Number of participants with adverse events/abnormal laboratory values that are related to treatment | Through study completion, an expected average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic characteristics of ZGGS18 | Peak Plasma Concentration (Cmax) | Through Phase I study completion, an expected average of 1 year |
| Pharmacokinetic characteristics of ZGGS18 | Time to maximum concentration (Tmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shangdi Ning | Contact | +86-0512-57018308 | ningsd@zelgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ZGGS18 for Injection | Biological | Recommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18,intravenous infusion, once every 2 weeks. |
|
| Through Phase I study completion, an expected average of 1 year |
| Pharmacokinetic characteristics of ZGGS18 | Clearance (CL/F) | Through Phase I study completion, an expected average of 1 year |
| Pharmacokinetic characteristics of ZGGS18 | Area under drug concentration-time curve | Through Phase I study completion, an expected average of 1 year |
| Pharmacokinetic characteristics of ZGGS18 | Elimination rate constant (Ke) | Through Phase I study completion, an expected average of 1 year |
| Pharmacokinetic characteristics of ZGGS18 | Elimination half-life (t1/2) | Through Phase I study completion, an expected average of 1 year |
| Immunogenicity of ZGGS18 | Detection of anti-drug antibodies, if positive, further detection of neutralizing antibodies. Counting the number of patients and incidence of anti-drug antibodies and neutralizing antibodies | Through study completion, an expected average of 3 years |
| Efficacy of ZGGS18 | Objective response rate | Through study completion, an expected average of 3 years |
| Efficacy of ZGGS18 | Progression-free survival | Through study completion, an expected average of 3 years |
| Efficacy of ZGGS18 | Disease control rate | Through study completion, an expected average of 3 years |
| Efficacy of ZGGS18 | Duration of response | Through study completion, an expected average of 3 years |
| Efficacy of ZGGS18 | Time to response | Through study completion, an expected average of 3 years |
| Efficacy of ZGGS18 | Time to progression | Through study completion, an expected average of 3 years |