Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504013-68-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7656594 in participants with advanced or metastatic prostate cancer. It will also identify recommended doses and regimens for RO7656594 for subsequent studies.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1: Dose Escalation | Experimental | Participants will receive RO7656594 administered at a specified dose on specific days in each 28-day cycle. The dose will be increased in successive cohorts until a study-specific threshold is reached. |
|
| Stage 2: Expansion | Experimental | Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7656594 | Drug | RO7656594 will be administered orally at specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days) | |
| Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs) | Days 1-28 of Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of RO7656594 | The pharmacokinetics (PK) of RO7656594 will be evaluated in plasma. | Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days) |
| Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol specified inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GO44537 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Recruiting | Scottsdale | Arizona | 85258 | United States | |
| Yale Cancer Center |
Not provided
| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days) |
| Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594 | From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days) |
| Recruiting |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Sarah Cannon Research Institute @ Florida Cancer | Recruiting | Orlando | Florida | 32827 | United States |
| University of Illinois Hospital & Health Sciences System | Recruiting | Chicago | Illinois | 60612 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Texas | 37203 | United States |
| St Vincent's Hospital Sydney | Recruiting | Darlinghurst | New South Wales | 2010 | Australia |
| Macquarie University Hospital | Recruiting | New South Wales | New South Wales | 2162 | Australia |
| Monash Health Monash Medical Centre | Recruiting | Clayton | Victoria | 3168 | Australia |
| Austin Hospital | Recruiting | Heidelberg | Victoria | 3084 | Australia |
| British Columbia Cancer Agency | Recruiting | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Princess Margaret Hospital | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Gustave Roussy | Recruiting | Villejuif | Val-de-Marne | 94805 | France |
| Centre Léon Bérard | Recruiting | Lyon | 69008 | France |
| Institut Paoli Calmettes | Recruiting | Marseille | 13009 | France |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System - PPDS | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center - PPDS | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center - PPDS | Recruiting | Seoul | 06351 | South Korea |
| Clinica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Vall d'Hebron - PPDS | Recruiting | Barcelona | 08035 | Spain |
| Clinica Universidad de Navarra-Madrid | Recruiting | Madrid | 28027 | Spain |
| Hospital Clinico San Carlos | Recruiting | Madrid | 28040 | Spain |
| Cambridge Clinical Research Centre | Recruiting | Cambridge | CB2 0AU | United Kingdom |
| Leicester Royal Infirmary | Recruiting | Leicester | LE1 5WW | United Kingdom |
| The Christie | Recruiting | Manchester | M20 4BX | United Kingdom |
| Royal Marsden Hospital - Surrey | Recruiting | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided