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

Sponsor

Gilead Sciences (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04747470

Collaborator

(none)

Enrollment

Locations

Arm

51.2

Anticipated Duration (Months)

8.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: GS-3583	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 25, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) [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.
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [First Dose up to 52 Weeks Plus 60 Days]
Percentage of Participants Experiencing Lab Abnormalities According to the NCI CTCAE Version 5.0 [First Dose up to 52 Weeks Plus 60 Days]

Secondary Outcome Measures

Pharmacokinetic (PK) Parameter: AUCtau of GS-3583 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	START Midwest	Grand Rapids	Michigan	United States	49546
2	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
3	Oregon Health & Science University	Portland	Oregon	United States	97239
4	NEXT Oncology	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director, Gilead Sciences

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Gilead Clinical Trials Website

Publications

None provided.

Responsible Party:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT04747470

Other Study ID Numbers:

GS-US-496-5657

First Posted:

Feb 10, 2021

Last Update Posted:

Jul 26, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Jul 26, 2022