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Recruiting Phase 1 NCT06619587

A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors

Phase 1 – testing safety in a small group of people
Conditions: Solid Tumor

Sponsor: Genentech, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 8
Australia (1)
St Vincent's Hospital Sydney
Darlinghurst , New South Wales
Canada (1)
British Columbia Cancer Agency
Vancouver , British Columbia
Israel (1)
Rambam Health Care Campus
Haifa
Singapore (1)
National University Hospital
Singapore
South Korea (1)
Seoul National University Bundang Hospital
Seongnam
Spain (1)
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona
United Kingdom (1)
Western General Hospital;Edinburgh Cancer Center
Edinburgh , Midlothian
United States (1)
UC San Diego Moores Cancer Center
La Jolla , California
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
14.11.2024
Completion date
31.05.2028
Registry ID
NCT06619587
Source
anzctr
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