Advanced Solid Tumors
Conditions
Brief summary
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).
Interventions
DRUGGS-2426
Administered Orally
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 1 * 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. * 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 . * 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) | First dose up to 30 days post last dose (up to 105 weeks) |
| Percentage of Participants Experiencing Clinical Laboratory Abnormalities | First dose up to 30 days post last dose (up to 105 weeks) |
| Percentage of Participants Experiencing Any Dose-limiting Toxicities (DLTs) | First dose up to 21 days post first dose |
| Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD) | First dose up to 21 days post first dose |
| Recommended Phase 2 Dose (RP2D) | Predose to end of study (up to 105 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of GS-2426 | Predose and postdose up to end of treatment (up to 105 weeks) | — |
| Pharmacokinetic (PK) Parameter: AUC0-24h of GS-2426 | Predose and postdose up to end of treatment (up to 105 weeks) | AUC0-24h is defined as the area under concentration versus time from 0 to 24 hours. |
| PK Parameters: Cmax of GS-2426 | Predose and postdose up to end of treatment (up to 105 weeks) | Cmax is defined as the maximum observed plasma drug concentration. |
| PK Parameters: Tmax of GS-2426 | Predose and postdose up to end of treatment (up to 105 weeks) | Tmax is defined as the time to peak plasma drug concentration of GS-2426. |
Countries
United States
Contacts
CONTACTGilead Clinical Study Information Center
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed