Study of GS-2426 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 goal of this clinical study is to learn more about the study drug GS-2426, and how safe and tolerable it is in participants with advanced methylthioadenosine phosphorylase (MTAP)-deleted solid tumors.
The primary objective of this study is to evaluate the safety and tolerability of GS-2426 in participants with MTAP-deleted advanced solid tumors and to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended phase II dose (RP2D).
Eligibility criteria
Qualifiers
Participants 18 years of age or older (≥ 19 years old for participants in South Korea).
Histologically or cytologically confirmed advanced malignant solid tumors, who have progressed on, are intolerant to or are ineligible for standard therapy, or have no standard treatment options.
Participant tumors are methylthioadenosine phosphorylase (MTAP)-deficient.
Adequate organ function
Disqualifiers
Participants with plans to breastfeed during the study period or within 7 days following the last dose of study intervention.
Have not recovered (ie, returned to Grade 1 or baseline) from clinically significant adverse events (AEs) due to a previously administered agent or a previous intervention as assessed by the investigator.
Active second malignancy. Individuals with a history of malignancy who have been completely treated with no evidence of active cancer for 5 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence may be enrolled.
Requirement for ongoing therapy with any prohibited medications .
Trial design
Treatments tested in this trial
- GS-2426
Treatment groups
174 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov