Trial NCT07601243
Study of GS-2426 in Participants With Advanced Solid Tumors
- Phase
- Phase 1
- Sponsor
- Gilead Sciences
- Conditions
- Advanced Solid Tumors
- 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 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
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Performance status
* All participants must provide a pretreatment tumor tissue sample.
Key Exclusion Criteria:
* Participants with plans to breastfeed during the study period or within 7 days following the last dose of study intervention.Pregnancy
* 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.Prior malignancy
* Requirement for ongoing therapy with any prohibited medications .
* Prior therapy with a protein arginine methyltransferase 5 (PRMT5) inhibitor or methionine adenosine transferase 2a (MAT2A) inhibitor.
* Have serious infection requiring antibiotics within 14 days prior to the first dose.
* Uncontrolled concurrent diseases
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Restrictions found (3)
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text - PregnancyConditionalexclusionShow in the text
- Prior malignancyConditionalexclusion
no evidence of active cancer for 5 years
Show in the text
Recruiting in Massachusetts
- Beth Israel Deaconess Medical Center · Boston, Suffolk County