GS-3583
/ Gilead
- LARVOL DELTA
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September 03, 2024
Study to Assess the Effects of GS-3583 in Participants With Advanced Solid Tumors
(clinicaltrials.gov)
- P1 | N=13 | Terminated | Sponsor: Gilead Sciences | Phase classification: P1b ➔ P1
Metastases • Phase classification • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck
August 22, 2024
Pharmacokinetics, pharmacodynamics, and safety of GS-3583, a FLT3 agonist Fc fusion protein, from single-ascending-dose phase I study in healthy participants.
(PubMed, Clin Transl Sci)
- "PD analysis shows that administration of GS-3583 resulted in transient, dose-dependent increases in cDC1 cells that returned to baseline within 3 weeks of drug administration. The pharmacokinetics and pharmacodynamics of GS-3583 following single dosing were characterized in this study which enabled subsequent phase Ib assessments in patients with advanced solid tumors."
Clinical • Journal • P1 data • PK/PD data • Oncology • Solid Tumor • CD8 • FLT3
May 26, 2024
A Minimal PBPK/PD Model with Expansion-Enhanced Target-Mediated Drug Disposition to Support a First-in-Human Clinical Study Design for a FLT3L-Fc Molecule.
(PubMed, Pharmaceutics)
- "In addition to the preclinical PK data of FLT3L-Fc in cynomolgus monkeys, clinical PK and PD data from other FLT3-agonist molecules (GS-3583 and CDX-301) were used to inform the model and project the expansion profiles of conventional DC1s (cDC1s) and total DCs in peripheral blood. This work constitutes an essential part of our model-informed drug development (MIDD) strategy for clinical development of FLT3L-Fc by projecting PK/PD in healthy volunteers, determining the first-in-human (FIH) dose, and informing the efficacious dose in clinical settings. Model-generated results were incorporated in regulatory filings to support the rationale for the FIH dose selection."
Journal • P1 data • FLT3
April 24, 2024
FLT3 agonists and secondary hematopoietic malignancies: a potential class effect.
(PubMed, Clin Cancer Res)
- "Expansion of cDC cells via FLT3 agonism has promising therapeutic potential in the treatment of advanced solid tumors. Here, we discuss the results of a clinical trial using GS-3583, an FLT3 agonist, that was stopped after a patient in the study developed acute myeloid leukemia."
Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor
January 31, 2024
Phase I Study of GS-3583, a FLT3 Agonist Fc Fusion Protein, in Patients with Advanced Solid Tumors.
(PubMed, Clin Cancer Res)
- "GS-3583 was relatively well tolerated and induced dose-dependent expansion of cDCs in the periphery of patients with advanced solid tumors. However, development of a second primary malignancy provides a cautionary tale for the FLT3 agonist mechanism."
Journal • Metastases • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor • FLT3
May 28, 2023
Engaging FLT3 to Promote Dendritic Cell Expansion and Drive the Adaptive Anti-Tumor Immune Response
(PEGS 2023)
- "GS-3583 is a fusion protein composed of the extracellular domain (ECD) of human FLT3 ligand (FLT3L) combined with a modified fragment crystallizable (Fc) region of human IgG4. GS-3583 is a promising immunotherapy candidate."
Oncology • FLT3
December 05, 2022
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583 in Participants With Advanced Solid Tumors
(clinicaltrials.gov)
- P1b | N=13 | Terminated | Sponsor: Gilead Sciences | N=33 ➔ 13 | Trial completion date: Jul 2025 ➔ Nov 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2023 ➔ Nov 2022; Sponsor decision to prematurely discontinue the study, following an internal safety assessment of the molecule, GS-3583.
Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor
April 28, 2022
Phase 1b study of GS-3583, a novel FLT3 agonist Fc fusion protein, in patients with advanced solid tumors.
(ASCO 2022)
- P1b | "GS-3583 was safe and well tolerated and induced dose-dependent expansion of cDCs in the periphery in patients with advanced solid tumors up to doses of 12 mg. These findings support further dose escalation and clinical development of GS-3583 in combination with agents that would stimulate the expanded cDCs to produce anti-tumor responses."
Clinical • P1 data • Oncology • Pancreatic Cancer • Solid Tumor • CDK1 • FLT3
June 21, 2022
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583 in Participants With Advanced Solid Tumors
(clinicaltrials.gov)
- P1b | N=33 | Active, not recruiting | Sponsor: Gilead Sciences | Recruiting ➔ Active, not recruiting
Enrollment closed • Oncology • Solid Tumor
October 01, 2021
GS-3583, a novel FLT3 agonist Fc fusion protein, expands conventional dendritic cells in healthy volunteers
(SITC 2021)
- "Conclusions GS-3583 infusion was well tolerated and induced dose dependent expansion of dendritic cells in the periphery in healthy volunteers. In patients with cancer, this increase in dendritic cells can be utilized to enhance anti-tumor therapeutic effects of immuno-oncology therapies."
Clinical • Oncology • CD8 • CDK1 • FLT3
October 01, 2021
Pre-clinical validation of a FLT3L-fusion protein for dendritic cell expansion and anti-tumor efficacy
(SITC 2021)
- "Conclusions In vivo expansion of dendritic cells can convert uninflamed (cold) tumors to immunologically active (hot) tumors and initiate productive anti-tumor immune responses. These findings support the development GS-3583 as a promising candidate for cancer immunotherapy."
Preclinical • Oncology • FLT3
October 01, 2021
Pharmacokinetics and pharmacodynamics of GS-3583 in cynomolgus monkeys
(SITC 2021)
- "It was well tolerated at the maximal dose tested with no adverse clinical signs. Further clinical development of GS-3583 is warranted."
PK/PD data • Oncology • CDK1 • FLT3
April 28, 2021
[VIRTUAL] Phase 1b dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of GS-3583, a FLT3 agonist Fc fusion protein, in patients with advanced solid tumors.
(ASCO 2021)
- P1b | "Assessments include safety, PK, pharmacodynamics including cDCs, immunogenicity, and efficacy by RECIST 1.1 in CT/MRI imaging conducted every 8 weeks . Accrual at approximately 3-4 centers in the US is ongoing."
Clinical • P1 data • PK/PD data • Oncology • Solid Tumor • FLT3 • MRI
June 03, 2021
Clinical Oncology Findings From Seattle Cancer Care Alliance (SCCA) Clinicians to Be Featured at the 2021 ASCO Annual Meeting
(Businesswire)
- “Seattle Cancer Care Alliance (SCCA) announced today the presentations from the organization’s clinicians that will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8, 2021…Presentations will highlight results from trials in Phase 1, CAR T-cell therapy, breast cancer, bladder cancer, non-small cell lung cancer and hematologic cancers. Additionally, there are multiple studies on the impact of the COVID-19 pandemic on cancer diagnosis, clinical care and oncology clinical trials.”
Clinical data • Breast Cancer • Hematological Malignancies • HER2 Negative Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer
May 19, 2021
Gilead-Kite Oncology to Present Transformative Science From Growing Portfolio at ASCO 2021
(Businesswire)
- “Gilead Sciences, Inc…announced that 16 abstracts representing the breadth of the Gilead-Kite Oncology portfolio will be presented at the American Society of Clinical Oncology Annual Meeting from June 4-8, 2021. The abstracts, including two oral presentations, expand on the clinical profiles of Gilead’s antibody-drug conjugate (ADC), as well as Kite’s chimeric antigen receptor (CAR) T-cell therapies across a range of cancers, including in existing indications and for investigational uses.”
Clinical data • Breast Cancer • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Solid Tumor • Triple Negative Breast Cancer
April 28, 2021
[VIRTUAL] GS-3583, a novel FLT3 agonist Fc fusion protein, to expand conventional dendritic cells in healthy volunteers.
(ASCO 2021)
- "GS-3583 was safe and well tolerated and induced dose dependent expansion of dendritic cells in the periphery . In patients with cancer, this increase in dendritic cells can be utilized to enhance anti-tumor responses to immuno-oncology therapies."
Clinical • Oncology • CD8 • CDK1 • FLT3
April 06, 2021
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583 in Participants With Advanced Solid Tumors
(clinicaltrials.gov)
- P1b; N=33; Recruiting; Sponsor: Gilead Sciences; Not yet recruiting ➔ Recruiting
Enrollment open • Oncology • Solid Tumor
March 11, 2021
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583 in Participants With Advanced Solid Tumors
(clinicaltrials.gov)
- P1b; N=33; Not yet recruiting; Sponsor: Gilead Sciences; Trial completion date: Apr 2025 ➔ Jul 2025; Trial primary completion date: Jun 2023 ➔ Sep 2023
Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor
February 10, 2021
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583 in Participants With Advanced Solid Tumors
(clinicaltrials.gov)
- P1b; N=33; Not yet recruiting; Sponsor: Gilead Sciences
Clinical • New P1 trial • Oncology • Solid Tumor
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