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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
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This is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg/kg, 1.6 mg/kg and 2.0 mg/kg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg/kg,1.6 mg/kg or 2.0 mg/kg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W | Experimental |
| |
| YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W | Experimental |
| |
| YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YL201 | Drug | YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nature and Frequency with Dose-Limiting Toxicities (DLTs) | 21 days | |
| Adverse Events | Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5 | First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Up to approximately 3 years | |
| DOR | Up to approximately 3 years | |
| PFS |
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Inclusion Criteria:
1.18 years of age or older. 2. Histologically or cytologically confirmed diagnosis of ES-SCLC 3. Eastern Cooperative Oncology Group performance status of 0 or 1 4. Adequate hematologic and end-organ function
Exclusion Criteria:
Other protocol-defined inclusion/ exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MediLink Study Team | Contact | 86 0512-62858368 | clinicaltrials@medilinkthera.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1001 | Not yet recruiting | Washington D.C. | District of Columbia | 20057 | United States |
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| Atezolizumab | Drug | Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle |
|
| Up to approximately 3 years |
| OS | Up to approximately 3 years |
| AUC | Up to approximately 3 years |
| CL | Up to approximately 3 years |
| Vss | Up to approximately 3 years |
| t1/2 | Up to approximately 3 years |
| Cmax | Up to approximately 3 years |
| Site 1004 | Recruiting | Louisville | Kentucky | 40202 | United States |
|
| Site 1005 | Recruiting | Houston | Texas | 77030 | United States |
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| Site 1002 | Recruiting | Fairfax | Virginia | 22031 | United States |
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| Site 1201 | Recruiting | Namur | 5000 | Belgium |
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| Site 1703 | Recruiting | Meldola | 47014 | Italy |
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| Site 1702 | Recruiting | Ravenna | 48121 | Italy |
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| Site 1802 | Recruiting | Otwock | 05-400 | Poland |
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| Site 1804 | Recruiting | Poznan | 60-569 | Poland |
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| Site 1801 | Recruiting | PrzemyĆl | 37-700 | Poland |
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| Site 1901 | Recruiting | Craiova | 109 | Romania |
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| Site 2013 | Recruiting | Badajoz | 06080 | Spain |
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| Site 2014 | Recruiting | Barcelona | 08017 | Spain |
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| Site 2003 | Recruiting | Barcelona | 08023 | Spain |
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| Site 2002 | Recruiting | Madrid | 28034 | Spain |
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| Site 2005 | Recruiting | Madrid | 28040 | Spain |
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| Site 2004 | Recruiting | Madrid | 28223 | Spain |
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| Site 2011 | Recruiting | Madrid | 28850 | Spain |
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| Site 2010 | Recruiting | Manresa | 08242 | Spain |
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| Site 2009 | Recruiting | Valencia | 46010 | Spain |
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| Site 2015 | Recruiting | Valencia | 46026 | Spain |
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| Site 2201 | Recruiting | London | W12 0HS | United Kingdom |
|
| ID | Term |
|---|---|
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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