Health TrialsbyHealthPanel

Study of GS-0201 Alone and in Combination 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 main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors.

The primary objectives of this study are to:

* To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors * To identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and/or the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected advanced solid tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand and give written informed consent.

Assigned female or male at birth, 18 years of age or older, and meet the age of majority/adulthood per local regulations.

Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria by investigator assessment.

Disqualifiers

Pregnant or lactating females

Known hypersensitivity to any of the study drugs, its metabolites, or formulation excipients

Requirement for ongoing therapy with or use of any prohibited medications described in the protocol

Individuals with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with findings suggestive of MDS/AML

Trial design

Design model

Sequential

Treatments tested in this trial

  • GS-0201

    Drug

    Pill administered orally

  • Sacituzumab Govitecan

    Drug

    Administered intravenously

Treatment groups

278 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part A: GS-0201 Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Part B: Cohort B1: GS-0201 Monotherapy Dose ExpansionExperimental treatment 1 intervention
Group C: Part B: Cohort B2: GS-0201 Monotherapy Dose ExpansionExperimental treatment 1 intervention
Group D: Part C: Dose Escalation: GS-0201 + Sacituzumab Govitecan (SG)Experimental treatment 2 interventions
Group E: Part D: Cohort D1: Dose Expansion: GS-0201 + SGExperimental treatment 2 interventions
Group F: Part D: Cohort D2: Dose Expansion: GS-0201 + SGExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The Number of Participants with Dose Limiting Toxicities (DLTs) During Dose Escalation

DLTs are defined as any of the following treatment-emergent adverse events (AEs) regardless of attribution (graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), unless clearly related to an underlying disease or extraneous causes, with onset within the DLT-evaluation period for the corresponding dose.

Time frame
First dose up to 30 days post last dose (Up to approximately 109 weeks).
2

The Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
First dose up to 30 days post last dose (Up to approximately 109 weeks).
3

The Incidence of Laboratory Abnormalities

Time frame
First dose up to 30 days post last dose (Up to approximately 109 weeks).

Secondary outcomes

1

Pharmacokinetic (PK) Parameter: Area Under the Concentration (AUC)0-24 of GS-0201

AUC0-24 is defined as the concentration of drug over time between time 0 and time 24 hours.

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

PK Parameter: Cmax of GS-0201

Cmax is defined as the maximum observed drug concentration.

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

PK Parameter: Tmax of GS-0201

Tmax is defined as the time to maximum observed concentration.

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

PK Parameter: AUC0-168 of SG (Parts C and D only)

AUC0-168 is defined as the concentration of drug over time between time 0 and time 168 hours.

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
Apply now