Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGilead Sciences
About this trial
The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors.
The primary objectives of this study are to:
* To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors * To identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and/or the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected advanced solid tumors
Eligibility criteria
Qualifiers
Able to understand and give written informed consent.
Assigned female or male at birth, 18 years of age or older, and meet the age of majority/adulthood per local regulations.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria by investigator assessment.
Disqualifiers
Pregnant or lactating females
Known hypersensitivity to any of the study drugs, its metabolites, or formulation excipients
Requirement for ongoing therapy with or use of any prohibited medications described in the protocol
Individuals with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with findings suggestive of MDS/AML
Trial design
Treatments tested in this trial
- GS-0201
- Sacituzumab Govitecan
Treatment groups
278 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov