Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Recurrence

Glioma

Lymphoma

Neoplasms by Histologic Type

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Lymphosarcoma

Primary Central Nervous System Lymphoma

Neuroepithelioma

PRT811

This is a Phase 1 dose-escalation study of PRT811, a protein arginine N-methyltransferase (PRMT) 5 inhibitor, in subjects with advanced cancers and high-grade gliomas who have exhausted available treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT811.

This is a multicenter, open-label, dose-escalation, dose-expansion Phase 1 study of PRT811, a PRMT5 inhibitor, in subjects with advanced cancers without any approved or available treatment options including solid tumors, CNS lymphoma, and /or high-grade gliomas. The study will consist of 2 parts, a dose escalation part evaluating subjects with advanced solid tumors, CNS lymphoma, and/or high-grade glioma and a cohort expansion part which will evaluate the safety and efficacy of PRT811 in subjects with advanced solid tumors, and glioblastoma multiforme. For subjects, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of PRT811.

A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas

A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of PRT811 in Subjects With Advanced Solid Tumors, CNS Lymphoma, and Recurrent High-Grade Gliomas

Dose limiting toxicities will be evaluated through the first cycle

The MTD will be established for further investigation in participants with solid tumors and gliomas

The RP2D will be established for further investigation in participants with solid tumors and gliomas

Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy

PRT811 pharmacokinetics will be calculated including the maximum observed plasma concentration

Anti-tumor activity of PRT811 will be based on the measurement of objective responses

Prelude Therapeutics

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Thoracic Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Pembrolizumab

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Pemetrexed

Sotorasib

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 orally (PO) and carboplatin, paclitaxel, and pembrolizumab intravenously (IV)

Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 PO and carboplatin, pemetrexed, and pembrolizumab IV

Participants with MTAP-deleted NSCLC will receive a combination of AMG 193 PO and pembrolizumab IV

Participants with MTAP-deleted NSCLC and KRasG12C mutation will receive a combination of AM193 and sotorasib PO

Participants with MTAP-deleted NSCLC with brain metastases will receive AMG 193 PO

AMG 193

Amgen Call Center

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors.

AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

An SAE is defined as any AE that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas	NCT04089449	Advanced Solid ... Recurrent Gliom...	PRT811	18 Years -	Prelude Therapeutics
AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)	NCT06333951	Thoracic Tumors Non-small Cell ...	AMG 193 Carboplatin Paclitaxel Pembrolizumab Pemetrexed Sotorasib	18 Years - 100 Years	Amgen
A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas	NCT04089449	Advanced Solid ... Recurrent Gliom...	PRT811	18 Years -	Prelude Therapeutics

Spots Global Cancer Trial Database for prmt5 inhibitor