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This include two parts, part 1 is a dose escalation study and part 2 is a dose expansion study.
This study is a study of Max-40279-01 in combination with toripalimab in patients with advanced solid tumors. This study includes two Parts, the Part 1 will assess the safety and efficacy of the preset several dose levels of Max-40279-01 and toripalimab, and recommend a dose level of Max-40279-01 combined toripalimab for stage 2. The part 2 is designed to study the efficacy and safety of max-40279-01 combined toripalimab in advanced solid tumors or certain specific tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose level 1 of max-40279 combined dose level 1 of toripalimab | Experimental | "MAX-40279-01" and "toripalimab" |
|
| dose level 2 of max-40279 combined dose level 1 of toripalimab | Experimental | "MAX-40279-01" and "toripalimab" |
|
| dose level 2 of max-40279 combined dose level 2 of toripalimab | Experimental | "MAX-40279-01" and "toripalimab" |
|
| dose level 3 of max-40279 combined dose level 2 of toripalimab | Experimental | "MAX-40279-01" and "toripalimab" |
|
| recommend dose of max-40279 combined recommend dose level of toripalimab | Experimental | "MAX-40279-01" and "toripalimab" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "MAX-40279-01" and "Toripalimab" | Drug | "MAX-40279-01"combined with "Toripalimab" |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLTs | Dose limiting toxicity | 21 days |
| Incidence of Treatment-Emergent Adverse Events | Safety and tolerability assessed by incidence and severity of adverse events | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subsequent clinical recommended dose | Subsequent clinical recommended dose | 12 months |
| Cmax | Maximum plasma drug concentration of Max-40279 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanying MD Bao, Ph.D | Contact | +86-021-51370693 | hybao@maxinovel.com |
| Name | Affiliation | Role |
|---|---|---|
| xiangen MD Lu, Ph.D | Institute of The Sixth Affiliated Hospital Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of The Sixth Affiliated Hospital Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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| Approximately 6 months |
| Tmax | Time to maximum plasma concentration of Max-40279 | Approximately 6 months |
| AUC | Area under the time-concentration curve of Max-40279 | Approximately 6 months |
| T1/2 | Half-life of Max-40279 | Approximately 6 months |
| The blood concentration of toripalimab | The blood concentration of toripalimab | Approximately 6 months |
| ADA | Anti-drug antibody of toripalimab | 6 months |
| The efficacy end points: ORR、DCR,PFS,DOR,OS | Objective response rate,Disease control rate,Progression-free survival,Duration of response,Overall survival | 24 months |
| the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors | the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors | 24 months |