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Brief Title: Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors
Official Title: A Phase 1 Study to Evaluate the Safety and Tolerability of GS-9911 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
Study ID: NCT06082960
Brief Summary: The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-9911 when given alone or in combination with an anti-programmed cell death protein 1 (PD-1) monoclonal antibody in participants with advanced solid tumors. The primary objectives of this study are to: * Assess the safety and tolerability of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors * Identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended dose for expansion (RDE) of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Smilow Cancer Hospital Phase 1 Unit, New Haven, Connecticut, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
NEXT Oncology, San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
University Health Network, Princess Margaret Cancer Centre, Toronto, , Canada
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR