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The main goals of this study are to evaluate the safety and efficacy of casdozokitug in combination with toripalimab plus bevacizumab and to define a recommended dose for casdozokitug in combination with toripalimab plus bevacizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab | Experimental |
| |
| Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab | Experimental |
| |
| Arm C: Toripalimab + Bevacizumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Casdozokitug | Drug | Solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | From date of first dose to 90 days after date of last dose (Up to approximately 27 months) | |
| Objective Response Rate (ORR) by Investigator Review According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR by Investigator Review According to HCC Modified RECIST (mRECIST) | Up to approximately 2 years | |
| Duration of Response (DoR) by Investigator Review According to RECIST v1.1 | Up to approximately 2 years |
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Key Inclusion Criteria:
Exclusion Criteria:
Additional protocol-defined inclusion/exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Scottsdale | Scottsdale | Arizona | 85259 | United States | ||
| University of Arizona - Cancer Center |
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|
| Toripalimab | Drug | Solution for infusion |
|
| Bevacizumab | Drug | Solution for infusion |
|
| DoR by Investigator Review According to HCC mRECIST | Up to approximately 2 years |
| Progression-free Survival (PFS) by Investigator Review According to RECIST v1.1 | Up to approximately 2 years |
| PFS by Investigator Review According to HCC mRECIST | Up to approximately 2 years |
| Disease Control Rate (DCR) by Investigator Review According to RECIST v1.1 | Up to approximately 2 years |
| DCR by Investigator Review According to HCC mRECIST | Up to approximately 2 years |
| Overall Survival (OS) | Up to approximately 2 years |
| Maximum Concentration (Cmax) | Up to approximately 25 months |
| Minimum Concentration (Cmin) | Up to approximately 25 months |
| Time to Cmax (Tmax) | Up to approximately 25 months |
| Tucson |
| Arizona |
| 85719 |
| United States |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | United States |
| City of Hope | Duarte | California | 91010 | United States |
| City of Hope at Irvine Lennar | Irvine | California | 92618 | United States |
| Cancer & Blood Specialty Clinic | Lakewood | California | 90712 | United States |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90089 | United States |
| Sarcoma Oncology Center | Santa Monica | California | 90403 | United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| The Winship Cancer Institute Emory University | Atlanta | Georgia | 30322 | United States |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise | Idaho | 83712 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| UofL Health Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Christus St. Vincent Regional Medical Center | Santa Fe | New Mexico | 87505 | United States |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University of North Carolina (UNC) - Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James) | Columbus | Ohio | 43210 | United States |
| University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Prisma Health Cancer Institute | Greenville | South Carolina | 29605 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| UW Carbone Cancer Center - Cancer Connect | Madison | Wisconsin | 53706 | United States |
| Royal Brisbane and Women's Hospital | Herston | Brisbane | 4006 | Australia |
| Bankstown-Lidcombe Hospital | Bankstown | New South Wales | 2200 | Australia |
| Monash Health | Melbourne | Victoria | 3168 | Australia |
| St Vincent's Hospital Sydney | Darlinghurst | NSW 2010 | Australia |
| Linear Clinical Research | Nedlands | 6009 | Australia |
| Sunnybrook Health Sciences Centre - Bayview Campus | Toronto | Ontario | ON M4N 3M5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | ON M5G 2C4 | Canada |
| Prince of Wales Hospital | Shatin | New Territories | Hong Kong |
| Queen Mary Hospital | Hong Kong | Pok Fu Lam | Hong Kong |
| Humanity & Health Clinical Trial Centre | Hong Kong | Hong Kong |
| National Cancer Centre Singapore | Singapore | 168583 | Singapore |
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| Curie Oncology | Singapore | 329563 | Singapore |
| China Medical University Hospital | Taichung | Taichung City | 404 | Taiwan |
| National Cheng Kung University Hospital | Tainan | Tainan City | 704 | Taiwan |
| National Taiwan University Hospital | Tainan | Taipei City | 100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taipei City | 112 | Taiwan |
| Chi Mei Medical Center | Tainan | 71004 | Taiwan |
| Linkou Chang Gung Memorial Hospital (CGMHLK) | Taoyuan City | 33305 | Taiwan |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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