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The primary objective is to evaluate the safety and tolerability of RC288; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC288; and determine the recommended phase 2 dose (RP2D), and assess the efficacy of RC288 at the RP2D dose;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC288 (Phase I, dose escalation) | Experimental | There are six predefined escalating dose levels. |
|
| RC288 (Phase II, dose expansion) | Experimental | In the multi-indication cohort expansion phase, further assess the efficacy and safety of RC288 in various cancer types using the RP2D. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC288 For Injection | Drug | Intravenous (IV) administration of RC288. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicity (DLT) | 24 months | |
| Incidence and severity of adverse events/serious adverse events (graded according to NCI CTCAE v6.0) | 24 months | |
| Determine RP2D of RC288 | 24 months | |
| MTD and/or MAD | 24 months | |
| Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria and PCWG3 criteria | 24 months | |
| Non-Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heping Liu | Contact | +8610-65384976 | heping.liu@remegen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Changsha | Hunan | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| RC288 For Injection | Drug | Intravenous (IV) administration of RC288. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study. |
|