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This study adopts a multi-center, open-label, non-randomized trial design. It plans to enroll patients with Advanced solid tumor. Dose-escalation and PK-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with Different ADCs (DP303c/SYS6043/SYS6002/SYS6010) in this patient population, and to confirm the recommended phase 2 dose (RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sirolimus (albumin-bound)+ DP303c | Experimental |
| |
| sirolimus (albumin-bound)+ SYS6043 | Experimental |
| |
| sirolimus (albumin-bound)+ SYS6002 | Experimental |
| |
| sirolimus (albumin-bound)+ SYS6010 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sirolimus (albumin-bound) | Drug | intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence and frequency of adverse events (AE) and serious adverse events (SAE) | Up to approximately 36 weeks after the first participant is enrolled | |
| dose - limiting toxicities (DLT) | Up to approximately 36 weeks after the first participant is enrolled | |
| The recommended phase 2 dose | Up to approximately 36 weeks after the first participant is enrolled |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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Dose escalation and expansion
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| DP303c | Drug | intravenous infusion |
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| SYS6043 | Drug | intravenous infusion |
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| SYS6002 | Drug | intravenous infusion |
|
| SYS6010 | Drug | intravenous infusion |
|