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A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors
Sponsor: Genentech, Inc.
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
410
Start Date
2024-11-14
Completion Date
2028-05-31
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Phase I Arm A
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
Phase I Arm B
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies
Locations (36)
UC San Diego Moores Cancer Center
La Jolla, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialist-Lake Mary
Lake Mary, Florida, United States
University of Illinois
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
START - Midwest - EDOS
Grand Rapids, Michigan, United States
Montefiore Einstein Cancer Center
The Bronx, New York, United States
Mary Crowley Medical Research Center
Dallas, Pennsylvania, United States
Abramson Cancer Center;Univ of Pennsylvania
Philadelphia, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Peter Maccallum Cancer Centre
Parkville, Victoria, Australia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, Canada
Rambam Health Care Campus
Haifa, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel
The Chaim Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, Israel
National University Hospital
Singapore, Singapore
National Cancer Centre
Singapore, Singapore
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center.
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
START Madrid_Hospital Universitario HM Sanchinarro_CIOCC
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Western General Hospital;Edinburgh Cancer Center
Edinburgh, Midlothian, United Kingdom
NIHR UCLH Clinical Research Facility
London, United Kingdom
The Christie
Manchester, United Kingdom
Royal Marsden Hospital - Surrey
Sutton, United Kingdom