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This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I Arm A | Experimental | Dose escalation and expansion arm |
|
| Phase I Arm B | Experimental | Dose escalation and expansion arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase I Arm A | Drug | Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale | 4 Years | |
| Percentage of Participants with Dose Limiting Toxicity | 4 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of GDC-7035 at Specified Timepoints | 4 Years | |
| Blood Concentrations of GDC-7035 at Specified Timepoints | 4 Years | |
| Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GO45416 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S.) | 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 | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Moores Cancer Center | Recruiting | La Jolla | California | 92093-1503 | United States | |
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| 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 |
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| Phase I Arm B | Drug | Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies |
|
| 4 Years |
| Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal | 4 Years |
| Objective Response Rate Among Participants | 4 Years |
| Duration of Response Among Participants | 4 Years |
| Median Progression Free Survival Time Among Participants | 4 Years |
| Sarah Cannon Research Institute at HealthONE |
| Recruiting |
| Denver |
| Colorado |
| 80218 |
| United States |
| Yale Cancer Center | Recruiting | New Haven | Connecticut | 06510 | United States |
| Florida Cancer Specialist-Lake Mary | Completed | Lake Mary | Florida | 32746 | United States |
| University of Illinois | Recruiting | Chicago | Illinois | 60612 | United States |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| START - Midwest - EDOS | Recruiting | Grand Rapids | Michigan | 49546-7062 | United States |
| Montefiore Einstein Cancer Center | Recruiting | The Bronx | New York | 10461 | United States |
| Mary Crowley Medical Research Center | Recruiting | Dallas | Pennsylvania | 75230-2571 | United States |
| Abramson Cancer Center;Univ of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104-5127 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| O'Quinn Medical Tower at McNair Campus | Recruiting | Houston | Texas | 77054 | United States |
| St Vincent's Hospital Sydney | Recruiting | Darlinghurst | New South Wales | 2010 | Australia |
| Slade Health Inward goods | Recruiting | Mount Kuring-Gai | New South Wales | 2080 | Australia |
| Peter Maccallum Cancer Centre | Recruiting | Parkville | Victoria | 3052 | Australia |
| British Columbia Cancer Agency | Recruiting | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 1X6 | Canada |
| Sir Mortimer B Davis Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
| Gustave Roussy | Recruiting | Villejuif | Val-de-Marne | 94805 | France |
| Institut Bergonie | Recruiting | Bordeaux | 33076 | France |
| Centre Georges Francois Leclerc | Recruiting | Dijon | 21000 | France |
| Rambam Health Care Campus | Recruiting | Haifa | 3109601 | Israel |
| Hadassah University Hospital - Ein Kerem | Recruiting | Jerusalem | 9112001 | Israel |
| The Chaim Sheba Medical Center | Recruiting | Ramat Gan | 5262100 | Israel |
| Tel Aviv Sourasky Medical Center PPDS | Recruiting | Tel Aviv | 6423906 | Israel |
| National University Hospital | Recruiting | Singapore | 119074 | Singapore |
| National Cancer Centre | Recruiting | Singapore | 168583 | Singapore |
| Seoul National University Bundang Hospital | Recruiting | Seongnam | 13620 | South Korea |
| Asan Medical Center. | Recruiting | Seoul | 005505 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 3722 | South Korea |
| Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| START Madrid_Hospital Universitario HM Sanchinarro_CIOCC | Recruiting | Madrid | 28050 | Spain |
| Hospital Universitario Virgen de la Victoria | Recruiting | Málaga | 29010 | Spain |
| Hospital Universitario Virgen del Rocio - PPDS | Recruiting | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valencia | Recruiting | Valencia | 46010 | Spain |
| Western General Hospital;Edinburgh Cancer Center | Recruiting | Edinburgh | Midlothian | EH4 2LF | United Kingdom |
| NIHR UCLH Clinical Research Facility | Recruiting | London | W1T 7HA | United Kingdom |
| The Christie | Recruiting | Manchester | M20 4BX | United Kingdom |
| Royal Marsden Hospital - Surrey | Recruiting | Sutton | SM2 5PT | United Kingdom |