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This study was an open-label phase I study to evaluate the safety, tolerability, PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies.
This study includes 4 Parts: Part 1 (dose escalation and dose extension for QW administration), Part 2 (dose escalation and dose extension for Q2W administration), Part 3 (dose escalation and dose extension for Q3W administration), and Part 4 (indication extension, such as HER2 expression, PD-L1 high expression, driver gene negative newly treated advanced NSCLC, or other tumors).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, QW IV. Dose extension will be carried out at the selected level. |
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| Part 2 | Experimental | Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, Q2W IV. Dose extension will be carried out at the selected level. |
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| Part 3 | Experimental | Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, Q3W IV. Dose extension will be carried out at the selected level. |
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| Part 4 | Experimental | Indication extension will be carried out at the selected level,including 3 dosage levels. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSGJ-705 | Drug | anti-PD-1 and anti-HER2 bispecific antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLTs | Dose limiting toxicity | 14 days |
| AE | Safety and tolerability assessed by incidence and severity of adverse events | up to 1 year |
| MTD or MAD | maximum tolerated dose or the maximum administered dose if MTD is not reached | up to 1 year |
| RP2D | the recommended phase II dose | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | up to 1 year |
| PFS | Progression-free Survival | up to 1 year |
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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 | |
|---|---|---|---|---|
| Jinming Yu, MD,Ph.D | Contact | +86-13806406293 | sdyujinming@126.com | |
| Yuping Sun, MD,Ph.D | Contact | +86-13370582181 | 13370582181@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | China |
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| Cmax | Maximum Plasma Concentration | up to 1 year |
| T1/2 | Half-life | up to 1 year |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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