Trial NCT07128303
Study of GS-5319 Given Alone or in Combination in Adults With Solid Tumors
- Phase
- Phase 1
- Sponsor
- Gilead Sciences
- Conditions
- Advanced Solid Tumor
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Key Inclusion Criteria:
* 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.Performance status
* Adequate organ function
* Age ≥ 18yrs old ( ≥ 19 years old for patients in South Korea)
* Participants must meet the following tissue requirements:
* pretreatment tumor tissue is required
Key Exclusion Criteria:
* 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.Prior malignancy
* Positive serum pregnancy test or participant who is breastfeeding.Pregnancy
* 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.
* Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.
* Ascites or pleural effusion that is symptomatic and/or requiring medical intervention.
* Active human immunodeficiency virus (HIV)/hepatitis B virus (HBV)/hepatitis C virus (HCV) infectionHIV
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Restrictions found (4)
- HIVOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 to 1
Show in the text - PregnancyOutrightexclusionShow in the text
- Prior malignancyConditionalexclusion
no evidence of active cancer for 3 years
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County
- Beth Israel Deaconess Medical Center · Boston, Suffolk County