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This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 alone or in combination with a checkpoint inhibitor treatment in participants with locally advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a Dose Escalation | Experimental | Participants will receive XmAb24306 until study treatment discontinuation or study termination. |
|
| Phase 1a Dose Expansion | Experimental | Participants will receive XmAb24306 until study treatment discontinuation or study termination. |
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| Phase 1b Dose Escalation | Experimental | Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination. |
|
| Phase 1b Dose Expansion | Experimental | Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XmAb24306 | Drug | Participants will receive intravenous (IV) XmAb24306. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | Up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of XmAb24306 | Baseline, then at pre-defined intervals for the first year of treatment or until participant discontinues study treatment | |
| Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
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Key General Inclusion Criteria
Key General Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| Stanford Health Centre - Palo Alto |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Atezolizumab | Drug | Participants will receive IV XmAb24306 followed by IV atezolizumab |
|
|
| XmAb24306 | Drug | Participants will receive IV XmAb24306 followed by IV atezolizumab. |
|
|
| Up to approximately 4 years |
| Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 | Up to approximately 4 years |
| Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 | Up to approximately 4 years |
| ORR as Based on Radiographic Assessment by the Investigator Using Modified RECIST v1.1 for Immune-Based Therapeutics (iRECIST) | Up to approximately 4 years |
| DOR as Based on Radiographic Assessment by the Investigator Using iRECIST | Up to approximately 4 years |
| PFS as Based on Radiographic Assessment by the Investigator Using iRECIST | Up to approximately 4 years |
| Overall Survival (OS) | Up to approximately 4 years |
| Palo Alto |
| California |
| 94304 |
| United States |
| University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158-2545 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| City of Hope Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | United States |
| Parkville Cancer Clinical Trial Unit (PCCTU) | Melbourne | Victoria | 3000 | Australia |
| GasthuisZusters Antwerpen | Wilrijk | Antwerp | 2610 | Belgium |
| Hospital de Clinicas de Porto Alegre HCPA PPDS | Porto Alegre | Rio Grande do Sul | 90560-030 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | 01246-000 | Brazil |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| Istituto Europeo Di Oncologia | Milan | Lombardy | 20141 | Italy |
| Istituto Clinico Humanitas | Rozzano | Lombardy | 20089 | Italy |
| Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis | Amsterdam | North Holland | 1066 CX | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System - PPDS | Seoul | 03722 | South Korea |
| Asan Medical Center - PPDS | Seoul | 05505 | South Korea |
| Samsung Medical Center - PPDS | Seoul | 06351 | South Korea |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Clinica Universidad de Navarra-Madrid | Madrid | 28027 | Spain |
| START Madrid-FJD, Hospital Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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