MC# 19-38 - A Phase I Study of GS-1423 in Subjects with Advanced Solid Tumors

  • Agent(s): GS-1423
  • Disease Type(s): Gastric, Solid Tumor
  • Phase(s): I
  • Drug Classification(s):
  • Molecular Target(s):

Mechanism of Action

Purpose

In this study, the sponsor and investigators want to learn:

  • How much of GS-1423 can be given with an acceptable level of side effects
  • About the safety and tolerability of GS-1423
  • How proteins that indicate the status of your disease are affected with use of GS-1423
  • How much of GS-1423 is absorbed into the blood and how fast it is removed
  • If your body develops proteins that work against GS-1423
  • If research tests can be used in the future to predict who will benefit from GS-1423
Inclusion Criteria
  1. Voluntarily agree to participate by giving written informed consent
  2. Age ≥18 years
  3. 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
  4. Measurable Disease: Have measurable disease on imaging based on RECIST Version 1.1
  5. Have a life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Exclusion Criteria
  1. 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
  2. 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
  3. 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)
  4. 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.  Subjects with other previous malignancies are eligible if disease-free for >2 years.
  5. Has a known CNS metastasis(es), unless metastases are treated and stable and the subject does not require systemic steroids
  6. Has active or history of autoimmune disease that has required systemic treatment within 2 years of the start of trial treatment (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Location

  • Dallas, TX - Mary Crowley Cancer Research - Medical City
More Info: https://clinicaltrials.gov/ct2/show/NCT03954704

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Re: MC# 19-38