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This is a two-part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of TJ107 in Chinese patients with advanced solid tumors. Approximately a total of 36 ~ 60 patients will be enrolled into the dose escalation cohorts (Part A), and expansion cohorts (Part B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TJ107 | Experimental | Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TJ107 | Drug | Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities | Safety and tolerability of TJ107. Incidence of dose-limiting toxicities (DLTs) | 28days after first dose |
| Adverse events | Safety and tolerability of TJ107. Incidence of adverse events | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Serious adverse events | Safety and tolerability of TJ107. Incidence of serious adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events(CI CTCAE 5.0) | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | Maximum tolerated dose (MTD) | through study completion, an average of 1 year |
| Maximum effective dose | Maximum effective dose (MED) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The sixth Affiliated Hospital, Sun Yat-sen University | Guanzhou | Guangdong | 510655 | China | ||
| the First Affiliated Hospital of China Medical University |
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| through study completion, an average of 1 year |
| Recommended phase II dose | Recommended phase II dose (RP2D) | through study completion, an average of 1 year |
| Shenyang |
| Liaoning |
| 110001 |
| China |
| Shanghai East Hospital | Shanghai | Shanghai Municipality | 200120 | China |
| Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of the Medical | Hangzhou | Zhejiang | 310016 | China |