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This study will assess the safety, tolerability and efficacy of every-2-week dosing of QLF31907 injection in patients with advanced melanoma and urothelial carcinoma.
This study is divided into two parts. The first part is the safety and tolerability observation period, mainly observing the safety and tolerability of QLF31907. The second part is mainly the efficacy observation period, further evaluating the efficacy and safety of QLF31907 in patients with advanced melanoma and urothelial carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLF31907 | Experimental | single arm with QLF31907 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLF31907 | Drug | Intravenous infusion once every two weeks. The dose administered in part 2 will depend on the outcome of part 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| (part 1)Dose-limiting toxicity(DLT) | 28days | |
| (part 2) Objective response rate(ORR) | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| (part 2) Safety index: adverse event(AE), serious adverse event (SAE), treatment-related adverse event(TRAE) | up to 2 years | |
| (part 2) Progression-free survival(PFS) | up to 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Guo, MD | Contact | 010-88121122 | Guoj307@126.com | |
| Lu Si, MD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| (part 2) Overall survival(OS) |
| up to 2 years |
| (part 2) Maximum observed plasma concentration (Cmax) | up to 2 years |
| (part 2) Positive rate of anti-drug antibody(ADA) | up to 2 years |
| Fujian Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350014 | China |
|
| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410011 | China |
|
| Jilin Cancer Hospital | Not yet recruiting | Changchun | Jilin | 130021 | China |
|
| The First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130021 | China |
|
| West China Hospital | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
|
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |