Brief Summary
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.
Brief Title
A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors
Central Contacts
Central Contact Role
Contact
Central Contact Phone
888-662-6728 (U.S.)
Central Contact Email
global-roche-genentech-trials@gene.com
Completion Date
Completion Date Type
Estimated
Conditions
Solid Tumor
Eligibility Criteria
Inclusion Criteria:
* Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm
Exclusion criteria:
* Malabsorption or other condition that would interfere with enteral absorption
* Active brain metastases
* Clinically significant cardiovascular dysfunction or liver disease
* Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm
Exclusion criteria:
* Malabsorption or other condition that would interfere with enteral absorption
* Active brain metastases
* Clinically significant cardiovascular dysfunction or liver disease
Inclusion Criteria
Inclusion Criteria:
* Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm
* Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06619587
Org Class
Industry
Org Full Name
Genentech, Inc.
Org Study Id
GO45416
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase I/II Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation
Primary Outcomes
Outcome Measure
Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale
Outcome Time Frame
4 Years
Outcome Measure
Percentage of Participants with Dose Limiting Toxicity
Outcome Time Frame
4 Years
Secondary Outcomes
Outcome Time Frame
4 Years
Outcome Measure
Plasma Concentrations of GDC-7035 at Specified Timepoints
Outcome Time Frame
4 Years
Outcome Measure
Blood Concentrations of GDC-7035 at Specified Timepoints
Outcome Time Frame
4 Years
Outcome Measure
Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal
Outcome Time Frame
4 Years
Outcome Measure
Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal
Outcome Time Frame
4 Years
Outcome Measure
Objective Response Rate Among Participants
Outcome Time Frame
4 Years
Outcome Measure
Duration of Response Among Participants
Outcome Time Frame
4 Years
Outcome Measure
Median Progression Free Survival Time Among Participants
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Fernand Bteich
Investigator Email
fbteich@montefiore.org
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology