Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Part 1 will evaluate a dosing schedule for a total of 28 days in each cycle. The starting dose for Cycle 1 will be escalated in the next dose escalation cohort until MTD is reached.

Part 2 will evaluate efficacy after an induction phase. The induction phase consists of a treatment regimen at RP2D determined in Part 1.

GSK3745417

This is a Phase 1, open label, two-part study to determine recommended phase 2 dose (RP2D) and schedule of GSK3745417 administration in participants with relapsed/refractory AML or HR-MDS.

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

A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D and Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (HR-MDS)

IPD for this study will be made available via the Clinical Study Data Request site.

Severity for each AE will be reported during the study and will assign a grade according to the National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v5.0.

Severity for each SAE will be reported during the study and will assign a grade according to the NCI-CTCAE v5.0.

An AE will be considered a DLT if the investigator considers it to be clinically relevant and attributed (definitely, probably, or possibly) to the study intervention and meets at least 1 of the DLT criteria. Severity for DLT will be reported according to the NCI-CTCAE v5.0.

ORR is defined as the percentage of participants with a complete remission (CR), CR with incomplete platelet recovery (CRp), CR with incomplete count recovery (CRi), or a partial remission (PR) as per response criteria for AML and HR MDS respectively.

Severity for each AE will be reported during the study and will assign a grade according to the NCI-CTCAE v5.0.

GlaxoSmithKline

Death

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Antibodies

Antibodies, Monoclonal

Dostarlimab

Immunoglobulins

Interferons

GSK Clinical Trials

This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose escalation phase.

In Part 1A, escalating doses of GSK3745417 will be evaluated and in Part 2A, escalating doses of GSK3745417 in combination with dostarlimab will be evaluated as guided by the Bayesian Logistic Regression Model (BLRM).

A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors

A Phase I First Time in Human Open Label Study of GSK3745417 Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT05424380	Leukemia, Myelo...	GSK3745417	18 Years - 75 Years	GlaxoSmithKline
A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors	NCT03843359	Neoplasms	GSK3745417 Dostarlimab	18 Years -	GlaxoSmithKline
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	NCT05424380	Leukemia, Myelo...	GSK3745417	18 Years - 75 Years	GlaxoSmithKline

Spots Global Cancer Trial Database for gsk3745417

Every month we try and update this database with for gsk3745417 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gsk3745417

Every month we try and update this database with for gsk3745417 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gsk3745417 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.