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This study was an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSS59 as a single agent in patients with advanced malignancies.
This study includes 4 Parts: Part A1 (dose escalation and dose extension for QW administration), Part A2 (dose escalation and dose extension for Q2W administration), Part A3 (dose extension for Q3W administration), and Part B (indication extension, such as advanced gastric or gastroesophageal junction adenocarcinoma with MUC17 positive, failure of standard therapy, or intolerance to standard therapy , or other tumors).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A1 | Experimental | Dose escalation will be conducted using accelerated titration and traditional 3+3 design. Dose Escalation Level includes 12 levels, QW IV. Dose extension will be carried out at the selected level. |
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| Part A2 | Experimental | Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation Level includes 12 levels, Q2W IV. Dose extension will be carried out at the selected level. |
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| Part A3 | Experimental | Dose extension will be carried out at the selected dose level, Q3W, IV. |
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| Part B | Experimental | Indication extension will be carried out at the selected level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSS59 | Drug | A humanized antibody targeting MUC17 |
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| Measure | Description | Time Frame |
|---|---|---|
| DLTs | Dose limiting toxicity | 21 days |
| Safety and tolerability | Safety and tolerability assessed by incidence and severity of adverse events | during the intervention，Within 28 days of the last dose |
| MTD and RP2D | Determine the maximum tolerated dose and determine the recommended phase II dose | through study completion, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of SSS59 | Maximum concentration | baseline, during the intervention and at the end of the study |
| Tmax of SSS59 | Time to peak drug concentration |
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Inclusion Criteria:
Exclusion Criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Li, MD | Contact | 86+13818207333 | Leeqi2001@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai First People's Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| baseline, during the intervention and at the end of the study |
| AUC0-last of SSS59 | the area under the curve (AUC) up to the last measurable concentration | baseline, during the intervention and at the end of the study |
| RO of SSS59 | Receptor Occupancy | baseline, during the intervention and at the end of the study |
| Pharmacodynamic (PD) characteristics of SSS59 | change of cytokine | baseline, during the intervention and at the end of the study |
| Immunogenicity of SSS59 | ADA，NAB（if ADA is positive） | baseline, during the intervention and at the end of the study |
| Preliminary antitumor activity of SSS59 | Assessed according to Recist V1.1 | baseline, during the intervention and at the end of the study |