Study of GS-5319 in Adults With Solid Tumors
ConditionAdvanced Solid Tumor
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-5319, its dosing, safety and tolerability in adults with solid tumors, where the participants show a specific gene alteration in the tumor. The gene helps produce methylthioadenosine phosphorylase (MTAP) enzyme. MTAP enzyme helps in normal growth of cells.
The primary objectives of the study are to assess the safety and tolerability of GS-5319 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors and to identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or the recommended dose for expansion (RDE).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants diagnosed with histologically or cytologically confirmed solid tumor types who have progressed despite standard therapy, are intolerant to standard therapy, or are ineligible for standard therapy in the advanced setting (locally-advanced or metastatic).
Participant tumors are methylthioadenosine phosphorylase (MTAP)-deficient. Deoxyribonucleic acid (DNA) sequencing may be assessed locally such as by local next-generation sequencing (NGS) or by central laboratory assay when available.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
Adequate organ function
Disqualifiers
Active second malignancy. Participants with a history of malignancy who have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or participants with surgically cured tumors with low risk of recurrence may be enrolled.
Positive serum pregnancy test or participant who is breastfeeding.
Requirement for ongoing therapy with any prohibited medications.
Have not recovered (ie, returned to Grade 1 or baseline) from adverse events (AEs) due to a previously administered agent.
Trial design
Design model
Sequential
Treatments tested in this trial
GS-5319
DrugAdministered orally
Treatment groups
178 Participants
are divided into 2 treatment groupsGroup A: Part A: GS-5319 Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Part B: GS-5319 Monotherapy Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs)
Time frame
First Dose up to 30 days post last dose (Up to 105 weeks)2
Percentage of Participants Experiencing Laboratory Abnormalities
Time frame
First Dose up to 30 days post last dose (Up to 105 weeks)3
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts
Time frame
Up to 21 daysSecondary outcomes
1
Plasma Concentration of GS-5319
Time frame
Predose and postdose up to end of treatment (up to 105 weeks)2
Pharmacokinetic (PK) parameter: AUC0-24 of GS-5319
AUC0-24 is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.
Time frame
Predose and postdose up to end of treatment (up to 105 weeks)3
PK parameter: Cmax of GS-5319
Cmax is defined the maximum observed plasma drug concentration.
Time frame
Predose and postdose up to end of treatment (up to 105 weeks)4
PK parameter: Tmax of GS-5319
Tmax is defined as the time to maximum observed concentration.
Time frame
Predose and postdose up to end of treatment (up to 105 weeks)Sponsors and contacts
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Source ClinicalTrials.gov