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Study of GS-1423 in Participants With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03954704
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : October 1, 2019
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: GS-1423 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of GS-1423 in Subjects With Advanced Solid Tumors
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: GS-1423
This 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.
Drug: GS-1423
Administered intravenously once every 2 weeks

Primary Outcome Measures :
  1. Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) During the First 28 Days of Treatment [ Time Frame: Up to 28 days ]

Secondary Outcome Measures :
  1. Pharmacokinetic (PK) Parameter: AUC of GS-1423 [ Time Frame: Predose and 2, 6, 24, 48, 96, 168 hours postdose ]
    AUC is defined as the area under the concentration versus time curve.

  2. PK Parameter: t1/2 of GS-1423 [ Time Frame: Predose and 2, 6, 24, 48, 96, 168 hours postdose ]
    t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

  3. Percentage of Participants Experiencing Anti-Drug Antibody (ADA) Formation [ Time Frame: Up to Posttreatment Month 3 ]
  4. Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: First dose date up to last dose date (maximum: 1 year) plus 30 days ]
  5. 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 ]
  6. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03954704

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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0)

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United States, Arizona
Scottsdale Healthcare Hospitals d/b/a HonorHealth Recruiting
Scottsdale, Arizona, United States, 85258
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Gilead Sciences
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences Identifier: NCT03954704     History of Changes
Other Study ID Numbers: GS-US-505-5452
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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