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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519622-20-00 | Registry Identifier | EU CT Number |
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This study aims to evaluate the safety and tolerability of RO7673396 in participants with advanced solid tumors harboring RAS mutation(s). This study consists of two stages: Stage 1 (Dose Escalation) and Stage 2 (Dose Expansion). Stage 1 will define the recommended dose(s) for expansion (RDEs) of RO7673396. Stage 2 will evaluate preliminary anti-tumor activity of the RDE(s) defined in Stage 1 and of other doses of interest for future development in selected solid tumor indications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage I | Experimental | Participants with advanced solid tumors harboring RAS mutations will receive multiple ascending doses of RO7673396, as per a pre-defined dosing regimen until unacceptable toxicity or disease progression (PD) and/or loss of clinical benefit as determined by the investigator. |
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| Stage II | Experimental | Participants with advanced solid tumors harboring RAS mutations will receive RO7673396 at the dose determined in Stage 1, until unacceptable toxicity or PD and/or loss of clinical benefit as determined by the investigator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7673396 | Drug | RO7673396 will be administered as per the schedule specified in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stage I: Number of Participants With Adverse Events (AEs) | Up to approximately 40 months | |
| Stage I: Number of Participants With Dose-limiting Toxicities (DLTs) | Up to Day 21 | |
| Stage II: Objective Response Rate (ORR) as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1) | Up to approximately 40 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of RO7673396 and its Metabolite(s) | Up to approximately 49 months | |
| Stage I: ORR as Assessed by the Investigator per RECIST V1.1 | Up to approximately 49 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: YO45758 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S.) | global-roche-genentech-trials@gene.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Recruiting | Duarte | California | 91010 | United States | |
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| Stage I and II: Duration of Response (DOR) as Assessed by the Investigator per RECIST V1.1 |
| Up to approximately 49 months |
| Stage I and II: Progression-free Survival (PFS) as Assessed by the Investigator per RECIST V1.1 | Up to approximately 49 months |
| University of Colorado - Anschutz Medical Campus - PPDS |
| Recruiting |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Smilow Cancer Hospital at Yale New Haven | Recruiting | New Haven | Connecticut | 06519-1110 | United States |
| Florida Cancer Specialists - Sarasota (North Catttlemen Rd) | Recruiting | Sarasota | Florida | 34232 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030-3721 | United States |
| South Texas Accelerated Research Therapeutics (START) | Recruiting | San Antonio | Texas | 78229-4427 | United States |
| St Vincent's Hospital Sydney | Recruiting | Darlinghurst | New South Wales | 2010 | Australia |
| Peter MacCallum Cancer Center | Recruiting | Parkville | Victoria | 3052 | Australia |
| Princess Margaret Hospital | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Sun Yat-Sen University Cancer Center - Huangpu Campus | Recruiting | Guangzhou | Guangdong | 510555 | China |
| Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery | Recruiting | Guangzhou | 510050 | China |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | 201315 | China |
| Hubei Cancer Hospital | Recruiting | Wuhan | 430079 | China |
| Rigshospitalet | Recruiting | København Ø | 2100 | Denmark |
| Prince of Wales Hospital | Recruiting | Hong Kong | Hong Kong |
| New Zealand Clinical Research - Auckland | Recruiting | Auckland | 1010 | New Zealand |
| New Zealand Clinical Research - Christchurch | Recruiting | Christchurch | 8011 | New Zealand |
| National Cancer Centre - 30 Hospital Blvd | Recruiting | Singapore | 168583 | Singapore |
| Clinica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
| National Cheng Kung University Hospital | Recruiting | Tainan | 70403 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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