Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • GS-2426

    Drug

    Administered Orally

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: Phase 1a: Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Phase 1b: Monotherapy Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE)

Time frame
First dose up to 30 days post last dose (up to 105 weeks)
2

Percentage of Participants Experiencing Clinical 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)

Time frame
First dose up to 21 days post first dose
4

Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD)

Time frame
First dose up to 21 days post first dose

Secondary outcomes

1

Plasma Concentration of GS-2426

Time frame
Predose and postdose up to end of treatment (up to 105 weeks)
2

Pharmacokinetic (PK) Parameter: AUC0-24h of GS-2426

AUC0-24h is defined as the area under concentration versus time from 0 to 24 hours.

Time frame
Predose and postdose up to end of treatment (up to 105 weeks)
3

PK Parameters: Cmax of GS-2426

Cmax is defined as the maximum observed plasma drug concentration.

Time frame
Predose and postdose up to end of treatment (up to 105 weeks)
4

PK Parameters: Tmax of GS-2426

Tmax is defined as the time to peak plasma drug concentration of GS-2426.

Time frame
Predose and postdose up to end of treatment (up to 105 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gilead Sciences

Lead sponsor

Source ClinicalTrials.gov
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