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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
410
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies
Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale
Time frame: 4 Years
Percentage of Participants with Dose Limiting Toxicity
Time frame: 4 Years
Plasma Concentrations of GDC-7035 at Specified Timepoints
Time frame: 4 Years
Blood Concentrations of GDC-7035 at Specified Timepoints
Time frame: 4 Years
Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal
Time frame: 4 Years
Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal
Time frame: 4 Years
Objective Response Rate Among Participants
Time frame: 4 Years
Duration of Response Among Participants
Time frame: 4 Years
Median Progression Free Survival Time Among Participants
Time frame: 4 Years
Reference Study ID Number: GO45416 https://forpatients.roche.com/
CONTACT
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UC San Diego Moores Cancer Center
La Jolla, California, United States
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Denver, Colorado, United States
RECRUITINGYale Cancer Center
New Haven, Connecticut, United States
RECRUITINGFlorida Cancer Specialist-Lake Mary
Lake Mary, Florida, United States
RECRUITINGUniversity of Illinois
Chicago, Illinois, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGSTART - Midwest - EDOS
Grand Rapids, Michigan, United States
RECRUITINGMontefiore Einstein Cancer Center
The Bronx, New York, United States
RECRUITINGMary Crowley Medical Research Center
Dallas, Pennsylvania, United States
RECRUITINGAbramson Cancer Center;Univ of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITING...and 26 more locations