GSK3745417 / GSK - LARVOL DELTA

A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS (clinicaltrials.gov) - P1 | N=18 | Terminated | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Terminated; The protocol was terminated on the basis of a reprioritization of organizational allocation of resources for clinical research programs.

Trial termination • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=97 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial primary completion date: Mar 2025 ➔ Apr 2024

Metastases • Trial primary completion date • Oncology • Solid Tumor

A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=98 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Apr 2024 ➔ Mar 2025 | Trial primary completion date: Apr 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | N=72 ➔ 18 | Trial completion date: Dec 2025 ➔ Mar 2024 | Trial primary completion date: Dec 2025 ➔ Mar 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Phase 1 First Time in Human (FTIH), Open Label Study of GSK3745417 Administered to Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=98 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Aug 2024 ➔ Apr 2024

Metastases • Trial completion date • Oncology • Solid Tumor

STING AGONIST FOR THE TREATMENT OF RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA AND HIGH-RISK MYELODYSPLASTIC SYNDROME: A FIRST-IN- CLINIC PHASE 1 STUDY OF GSK3745417 (EHA 2023) - P1 | "Accrual is ongoing. Clinical trial information: NCT05424380. Acute myeloid leukemia, Clinical trial, MDS, MDS/AML"

P1 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Solid Tumor • IFNA1 • IFNB1 • STING

Phase 1 First Time in Human (FTIH), Open Label Study of GSK3745417 Administered to Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=97 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | N=300 ➔ 97 | Trial completion date: May 2025 ➔ Aug 2024 | Trial primary completion date: Nov 2024 ➔ Apr 2024

Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A first-in-clinic phase 1 study of GSK3745417 STING agonist in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome (AACR 2023) - P1 | "Approximately 72 patients will be enrolled: approximately 22 patients in part 1 and 50 patients in part 2. Peripheral blood and bone marrow sampling will allow response assessment and biomarker analysis to understand the mechanism of GSK3745417 activity in AML and MDS."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Solid Tumor • IFNA1 • IFNB1 • STING

Sting Agonist GSK3745417 Induces Apoptosis, Antiproliferation, and Cell Death in a Panel of Human AML Cell Lines and Patient Samples (ASH 2022) - "GSK3745417 also blocked colony formation in primary AML samples from 5 donors.GSK3745417 is able to induce growth inhibition with transient compound incubation in vitro in as little as 30 minutes to 1 hour. Taken together, this data suggests a role for GSK3745417 as a therapeutic in AML/MDS indications through dual mechanisms of direct tumor cell killing and immune activation at a clinically relevant dose.The human biological samples were sourced ethically and their research use was in accord with the terms of the informed consents under an IRB/EC approved protocol."

Preclinical • Acute Myelogenous Leukemia • Oncology • Solid Tumor • IFNB1 • STING

Analyzing the Therapeutic Impact of di-ABZI on PBRM1-Deficient ccRCC Tumors (KCRS 2022) - "Since a compound from the same chemical group (GSK-3745417) is under phase 1 clinical trials in hundreds of cancer patients with solid tumors, if di-ABZI is proven to have potent antitumor activity, it will lay the foundation for clinical trial of the most effective compound in this group in kidney cancer patients...Once confirmed, this will establish a new paradigm. With the combined power of two kidney cancer researchers from two renowned institutions, we will make fundamental advances in both the understanding of kidney cancer and the potential treatment of the patients."

Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • PBRM1

A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2025 ➔ Dec 2025 | Trial primary completion date: Feb 2025 ➔ Dec 2025

Enrollment open • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Phase 1 First Time in Human (FTIH), Open Label Study of GSK3745417 Administered to Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=300 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jan 2025 ➔ May 2025 | Trial primary completion date: Jul 2024 ➔ Nov 2024

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Phase 1 First Time in Human (FTIH), Open Label Study of GSK3745417 Administered to Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=300; Recruiting; Sponsor: GlaxoSmithKline; Trial completion date: Aug 2024 ➔ Jan 2025; Trial primary completion date: Feb 2024 ➔ Jul 2024

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Phase 1 First Time in Humans (FTIH), Open Label Study of GSK3745417 Administered to Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=300; Recruiting; Sponsor: GlaxoSmithKline; Trial completion date: Jul 2024 ➔ Apr 2024

Clinical • Trial completion date • Chronic Kidney Disease • Gastrointestinal Cancer • Neutropenia • Oncology • Solid Tumor

Phase 1 First Time in Humans (FTIH), Open Label Study of GSK3745417 Administered to Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=300; Recruiting; Sponsor: GlaxoSmithKline; Trial completion date: Jul 2023 ➔ Jul 2024

Clinical • Trial completion date

Phase 1 First Time in Humans (FTIH), Open Label Study of GSK3745417 Administered to Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=300; Recruiting; Sponsor: GlaxoSmithKline; Trial completion date: Jul 2022 ➔ Jul 2023; Trial primary completion date: Jul 2022 ➔ Jul 2023

Clinical • Trial completion date • Trial primary completion date

Phase 1 First Time in Humans (FTIH), Open Label Study of GSK3745417 Administered to Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=300; Recruiting; Sponsor: GlaxoSmithKline; Trial completion date: Feb 2023 ➔ Jul 2022; Trial primary completion date: Feb 2023 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date