Clinical Trials /

Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583 in Participants With Advanced Solid Tumors

NCT04747470

Description:

The primary objectives of this study are to characterize the safety and tolerability of GS-3583 as monotherapy, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of GS-3583 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 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583 in Participants With Advanced Solid Tumors
  • Official Title: A Phase 1b Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583, a FLT3 Agonist Fc Fusion Protein, in Subjects With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: GS-US-496-5657
  • NCT ID: NCT04747470

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
GS-3583GS-3583 Dose Escalation

Purpose

The primary objectives of this study are to characterize the safety and tolerability of GS-3583 as monotherapy, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of GS-3583 as monotherapy in participants with advanced solid tumors.

Trial Arms

NameTypeDescriptionInterventions
GS-3583 Dose EscalationExperimentalParticipants will receive an escalating dose of GS-3583 for up to 52 weeks or until the participant meets study treatment discontinuation criteria.
  • GS-3583

Eligibility Criteria

        Key Inclusion Criteria:

          -  Histologically or cytologically confirmed locally advanced or metastatic malignant
             solid tumor that is refractory to or intolerant of standard therapy or for which no
             standard therapy is available

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

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

          -  Life expectancy of ≥ 3 months, in the opinion of the investigator

          -  Adequate organ function as assessed by hematological, renal, and hepatic parameters,
             and no clinically significant coagulopathy

        Key Exclusion Criteria:

          -  Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or
             major surgery within 3 weeks of Cycle 1 Day 1; a 1-week washout is permitted for
             palliative radiation to non-central nervous system (CNS) disease with sponsor approval

          -  Known severe hypersensitivity reactions (NCI CTCAE Grade ≥ 3) to fully human
             monoclonal antibodies or fusion proteins, GS-3583 formulation excipients, or severe
             reaction to immuno-oncology agents, such as colitis or pneumonitis requiring treatment
             with corticosteroids, any history of anaphylaxis, or uncontrolled asthma

          -  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.

          -  Previous history of hematological malignancy, monoclonal gammopathy of unknown
             significance (MGUS) or other preleukemic states (Presence of clonal hematopoiesis of
             indeterminate potential (CHIP)/age related clonal hematopoiesis (ARCH) is acceptable)

          -  Known CNS metastasis(es), unless metastases are treated and stable and the individual
             does not require systemic corticosteroids for management of CNS symptoms at least 1
             week prior to study treatment. Individuals with history of carcinomatous meningitis
             are excluded regardless of clinical stability.

          -  Active or history of autoimmune disease that has required systemic treatment within 2
             years of the start of study treatment (ie, with use of disease-modifying agents,
             corticosteroids, or immunosuppressive drugs)

               -  Note: Individuals with diabetes type 1, vitiligo, psoriasis, hypothyroid disease,
                  or hyperthyroid disease, not requiring immunosuppressive treatment are eligible.

        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)
Time Frame:Day 1 Through Day 28
Safety Issue:
Description:DLT is any toxicity (hematologic, non-hematologic, dosing/procedures-related toxicities, or grade 5 event (ie death)) occurring with GS-3583 monotherapy during the DLT assesment period (from Day 1 through Day 28) considered at least possibly related to GS-3583 monotherapy.

Secondary Outcome Measures

Measure:Pharmacokinetic (PK) Parameter: AUCtau of GS-3583
Time Frame:Cycle 1 through Cycle 13 (each cycle is 28 days) and up to 60-Day Follow-up Visit (60 days after last dose date) or End Of Treatment (up to 52 Weeks)
Safety Issue:
Description:AUCtau is defined as the area under the concentration versus time curve over the dosing interval.

Details

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

Last Updated

June 4, 2021