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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502615-11-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Chugai Pharmaceutical | INDUSTRY |
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The purpose of this study is to evaluate the safety and tolerability of RO7496353 in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and pancreatic ductal adenocarcinoma (PDAC).
The substudy will evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of RO7496353 in combination with atezolizumab in patients with locally advanced or metastatic urothelial carcinoma (UC).
The parent and substudy will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: NSCLC | Experimental | Participants with NSCLC will receive RO7496353, and atezolizumab, given as an intravenous (IV) infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression (PD). |
|
| Cohort B: GC | Experimental | Participants with GC will receive RO7496353, nivolumab, and oxaliplatin, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle along with either capecitabine or S-1, orally, twice daily on Days 1 to 14 of each cycle until unacceptable toxicity or symptomatic deterioration attributed to PD. |
|
| Cohort C: PDAC | Experimental | Participants with PDAC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, and gemcitabine, also given as an IV infusion on Days 1, 8, 15 of each 28-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD. |
|
| Substudy: UC | Experimental | Participants with UC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7496353 | Drug | RO7496353 will be administered as per the schedules specified in the respective arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). | Up to approximately 33 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of RO7496353 | Up to approximately 33 months | |
| Percentage of Participants With Anti-drug Antibody (ADA) to RO7496353 | Up to approximately 33 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A and C: Serum Concentration of Atezolizumab | Up to approximately 33 months | |
| Cohort A and C: Percentage of Participants With ADAs to Atezolizumab | Up to approximately 33 months |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA University of California Los Angeles | Los Angeles | California | 90095 | United States | ||
| Yale School of Medicine |
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| Atezolizumab | Drug | Atezolizumab will be administered as per the schedules specified in the respective arms. |
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| Capecitabine | Drug | Capecitabine will be administered as per the schedule specified in the respective arm. |
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| S-1 | Drug | S-1 will be administered as per the schedule specified in the respective arm. |
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| Nivolumab | Drug | Nivolumab will be administered as per the schedule specified in the respective arm. |
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| Oxaliplatin | Drug | Oxaliplatin will be administered as per the schedule specified in the respective arm. |
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| Nab-paclitaxel | Drug | Nab-paclitaxel will be administered as per the schedule specified in the respective arm. |
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| Gemcitabine | Drug | Gemcitabine will be administered as per the schedule specified in the respective arm. |
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| Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) |
| Up to approximately 33 months |
| Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1 | Up to approximately 33 months |
| Progression-free Survival (PFS) as Determined by the Investigator per RECIST v1.1 | Up to approximately 33 months |
| New Haven |
| Connecticut |
| 06510-3206 |
| United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| St Vincent'S Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital de Câncer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Fondazione Policlinico Universitario A Gemelli | Rome | Lazio | 00168 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda | Milan | Lombardy | 20162 | Italy |
| Centro Ricerche Cliniche Di Verona | Verona | Veneto | 37134 | Italy |
| National Cancer Center Hospital East | Chiba | 277-8577 | Japan |
| Kanagawa Cancer Center | Kanagawa | 241-8515 | Japan |
| Shizuoka Cancer Center | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of Japanese Foundation For Cancer Research | Tokyo | 135-8550 | Japan |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center - PPDS | Seoul | 06351 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy | Seoul | 120-752 | South Korea |
| NEXT Oncology-Hospital Quironsalud Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Clinica Universidad de Navarra-Madrid | Madrid | 28027 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Ankara City Hospital | Ankara | 06800 | Turkey (Türkiye) |
| Dokuz Eylul Universitesi Tip Fakultesi | Lzmir | 35340 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D013274 | Stomach Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000069287 | Capecitabine |
| C079198 | S 1 (combination) |
| D005641 | Tegafur |
| D000077594 | Nivolumab |
| D000077150 | Oxaliplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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