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| Name | Class |
|---|---|
| TransThera Sciences (Nanjing), Inc. | INDUSTRY |
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An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination with TT-00420 Tablet in Patients with Advanced Hepatocellular Carcinoma(HCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1(Safety Lead-In Phase) | Experimental | AK104 10mg/kg Q3W+TT-00420 10mg PO QD (n=3-6) |
|
| Cohort 2(Safety Lead-In Phase) | Experimental | AK112 20mg/kg Q3W + TT-00420 10mg PO QD(n=3-6) |
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| Cohort A(Expansion Cohort Phase) | Experimental | AK104 10mg/kg Q3W + TT-00420 10mg PO QD(n=20-30) |
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| Cohort B(Expansion Cohort Phase) | Experimental | AK112 20mg/kg Q3W + TT-00420 10mg PO QD(n=20-30) |
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| Cohort C(Expansion Cohort Phase) | Experimental | TT-00420 10mg PO QD(n=20-30) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TT-00420 (tinengotinib) | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | assessed by investigator per RECIST v1.1 | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | assessed by investigator per RECIST v1.1 | up to 2 years |
| Disease control rate(DCR) | assessed by investigator per RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Liu, M.D. | Contact | (0760)89873999 | clinicaltrials@akesobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital Tongji Medical College Huazhong University of Science And Technology | Recruiting | Wuhan | China | 430000 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| AK104 | Drug | intravenous |
|
| AK112 | Drug | intravenous |
|
| Up to 2 years |
| Duration of Response (DOR) | assessed by investigator per RECIST v1.1 | Up to 2 years |
| Time to Response (TTR) | assessed by investigator per RECIST v1.1 | Up to 2 years |
| Time to Progression (TTP) | assessed by investigator per RECIST v1.1 | Up to 2 years |
| Overall Survival(OS) | OS is defined as the time from randomization or first dosing to death due to any cause. | Up to 2 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |