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History of Changes for Study: NCT04747470
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583 in Participants With Advanced Solid Tumors
Latest version (submitted September 29, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 5, 2021 None (earliest Version on record)
2 March 9, 2021 Study Status and Oversight
3 March 18, 2021 Study Status
4 April 2, 2021 Recruitment Status, Study Status and Contacts/Locations
5 April 21, 2021 Study Status
6 May 13, 2021 Study Status
7 May 19, 2021 Study Status
8 June 3, 2021 Study Status
9 July 1, 2021 Study Status
10 July 22, 2021 Study Status
11 September 7, 2021 Study Status and Contacts/Locations
12 September 22, 2021 Contacts/Locations and Study Status
13 October 5, 2021 Study Status and Contacts/Locations
14 November 1, 2021 Study Status
15 December 17, 2021 Study Status and References
16 January 18, 2022 Study Status
17 April 7, 2022 Study Status
18 May 10, 2022 Study Status and Contacts/Locations
19 June 3, 2022 Study Status
20 June 16, 2022 Recruitment Status, Study Status and Contacts/Locations
21 July 22, 2022 Study Status
22 August 24, 2022 Study Status
23 September 29, 2022 Study Status
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Study NCT04747470
Submitted Date:  February 5, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: GS-US-496-5657
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
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2021
Overall Status: Not yet recruiting
Study Start: March 2021
Primary Completion: June 2023 [Anticipated]
Study Completion: April 2025 [Anticipated]
First Submitted: February 5, 2021
First Submitted that
Met QC Criteria:
February 5, 2021
First Posted: February 10, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
February 5, 2021
Last Update Posted: February 10, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Gilead Sciences
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Advanced Solid Tumors
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 33 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: GS-3583 Dose Escalation
Participants will receive an escalating dose of GS-3583 for up to 52 weeks or until the participant meets study treatment discontinuation criteria.
Drug: GS-3583
Administered as an intravenous (IV) infusion
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
[ Time Frame: Day 1 Through Day 28 ]

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.
2. Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
[ Time Frame: First Dose up to 52 Weeks Plus 60 Days ]

3. Percentage of Participants Experiencing Lab Abnormalities According to the NCI CTCAE Version 5.0
[ Time Frame: First Dose up to 52 Weeks Plus 60 Days ]

Secondary Outcome Measures:
1. 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) ]

AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.

Open or close this module Contacts/Locations
Central Contact Person: Gilead Clinical Study Information Center
Telephone: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
Study Officials: Gilead Study Director
Study Director
Gilead Sciences
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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