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The trial was stopped early on the initiative of the sponsor on the basis of a change in the research and development strategy without safety concerns
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| Name | Class |
|---|---|
| Sponsor GmbH | OTHER |
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This is an open-label phase I study to evaluate the safety, tolerability, and initial efficacy of JS004 injection combined with Toripalimab Injection in patients with advanced solid tumors who have failed standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS004 200 mg in combination with Toripalimab Injection 240 mg was administered every 3 weeks | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS004 | Drug | Usage and dosage: Inject 200mg once every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (AE) and serious adverse events (SAE) were assessed | Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Duration of Response | 2 years |
| DOR | Duration of Response | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate based on iRECIST criteria (Version 2017); | 2 years |
| DOR | duration of response based on iRECIST criteria (Version 2017); |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | China | |||
| Chongqing University Cancer Hospital |
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Single Group
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| Toripalimab Injection | Drug | Usage and dosage: Inject 240mg once every 3 weeks |
|
| DCR |
Disease Control Rate |
| 2 years |
| PFS | Progression-free survival | 2 years |
| ORR | Overall Response Rate | 2 years |
| TTR | Time to remission | 2 years |
| TTP | time to progression | 2 years |
| 2 years |
| DCR | disease control rate based on iRECIST criteria (Version 2017); | 2 years |
| PFS | progression-free survival based on iRECIST criteria (Version 2017); | 2 years |
| Chongqing |
| Chongqing Municipality |
| China |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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