Clinical Trials /

Study of GS-1423 in Participants With Advanced Solid Tumors

NCT03954704

Description:

The primary objectives of this study are to assess safety and tolerability including dose limiting toxicity (DLT) of GS-1423 and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of GS-1423 as monotherapy in participants with advanced solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of GS-1423 in Participants With Advanced Solid Tumors
  • Official Title: A Phase 1 Study of GS-1423 in Subjects With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: GS-US-505-5452
  • NCT ID: NCT03954704

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
GS-1423GS-1423

Purpose

The primary objectives of this study are to assess safety and tolerability including dose limiting toxicity (DLT) of GS-1423 and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of GS-1423 as monotherapy in participants with advanced solid tumors.

Trial Arms

NameTypeDescriptionInterventions
GS-1423ExperimentalThis study will utilize an accelerated titration design schema of dosing 1 participant each at the first 2 dose levels and with subsequent dosing conducted in a standard 3+3 dose escalation format. At the first 2 dose levels, if 2 drug related adverse events of Grade 2 or higher are observed, the 3+3 escalation scheme will be used at that dose and subsequent doses. Each participant will stay on the dose level and schedule assigned at trial entry. Participants will receive GS-1423 for up to 1 year or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.
  • GS-1423

Eligibility Criteria

        Key Inclusion Criteria:

          -  Diagnosis: Have a histologically or cytologically confirmed diagnosis of a locally
             advanced or metastatic solid tumor for which no standard therapy is available or
             standard therapy has failed

          -  Measurable disease: Have measurable disease on imaging based on Response Evaluation
             Criteria in Solid Tumors (RECIST) Version 1.1

          -  Have a life expectancy of at least 3 months and an Eastern Cooperative Oncology Group
             (ECOG) performance status of 0 or 1

        Key Exclusion Criteria:

          -  Is currently participating and receiving study therapy or has participated in a study
             of an investigational agent and received study therapy or used an investigation device
             within 3 weeks of the first dose of treatment

          -  Has persisting toxicity related to prior therapy of National Cancer Institute-Common
             Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE) Grade >1 severity

          -  Is expected to require any other form of systemic or localized antineoplastic therapy
             while on trial (including maintenance therapy with another agent, radiation therapy,
             and/or surgical resection)

          -  Has concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ
             of the cervix or superficial bladder cancer who has undergone potentially curative
             therapy with no evidence of disease. Individuals with other previous malignancies are
             eligible if disease-free for >2 years

          -  Has a known central nervous system metastasis(es), unless metastases are treated and
             stable and the individual does not require systemic steroids

          -  Has active or history of autoimmune disease that has required systemic treatment
             within 2 years of the start of trial treatment

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) During the First 28 Days of Treatment
Time Frame:Up to 28 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Pharmacokinetic (PK) Parameter: AUC of GS-1423
Time Frame:Predose and 2, 6, 24, 48, 96, 168 hours postdose
Safety Issue:
Description:AUC is defined as the area under the concentration versus time curve.
Measure:PK Parameter: t1/2 of GS-1423
Time Frame:Predose and 2, 6, 24, 48, 96, 168 hours postdose
Safety Issue:
Description:t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Measure:Percentage of Participants Experiencing Anti-Drug Antibody (ADA) Formation
Time Frame:Up to Posttreatment Month 3
Safety Issue:
Description:
Measure:Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame:First dose date up to last dose date (maximum: 1 year) plus 30 days
Safety Issue:
Description:
Measure:Percentage of Participants Experiencing Treatment-Emergent Grade 3 or 4 Laboratory Abnormalities
Time Frame:First dose date to last dose date (up to maximum of 1 year) plus 30 days
Safety Issue:
Description:
Measure:Percentage of Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG)
Time Frame:First dose date to last dose date (up to maximum of 1 year) plus 30 days
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Gilead Sciences

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