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Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

MRTX1719 RP2D administered to separate cohorts of patients with selected solid tumor malignancies with MTAP homozygous deletion to include the following: Mesothelioma, Pancreatic Adenocarcinoma, NSCLC, Malignant Peripheral Nerve Sheath Tumor, Other Solid Tumors

MRTX1719

BMS Study Connect Contact Center www.BMSStudyConnect.com

www.BMSStudyConnect.com NCT05245500 14 sites

Mayo Clinic

Research site

Bristol-Myers Squibb, MD

This is a Phase 1/2, open-label, multicenter, study of the safety, tolerability, PK, PD, and anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene.

This first-in-human clinical trial will begin with an exploration of MRTX1719 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure sufficient safety experience, PK information, compare food effect and relative bioavailability between capsules and tablets, and early evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX1719.

Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion

Mirati Therapeutics Inc.

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Hodgkin Disease

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

In Part A, participants with Relapsed/Refractory classical Hodgkin Lymphoma (cHL) will take AZD3470 tablets orally until PD, unacceptable toxicity, or withdrawal of consent.

In Part B, adult and adolescent participants with r/r cHL will take AZD3470 tablets orally until PD, unacceptable toxicity, or withdrawal of consent.

AZD3470 is a novel, potent and selective, secondgeneration, Methylthioadenosine (MTA)-selective, small molecule inhibitor of PRMT5.

AZD3470

AstraZeneca Clinical Study Information Center

This study is designed to evaluate the safety, tolerability, PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.

This is a FTiH modular, Phase I/II, open-label, multicentre, dose escalation and expansion study in participants with r/r haematologic malignancies. The study is designed to evaluate the safety, tolerability, PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.

This study will follow a modular protocol design evaluating AZD3470 as monotherapy and in combination with other anticancer agents. New cohorts (including further monotherapy expansion) and new modules for combination treatments may be added as protocol amendments in the future based on emerging supportive preclinical and/or clinical data.

Module 1 Part A includes a dose escalation of AZD3470 monotherapy in participants with r/r haematologic malignancies, initially focused on r/r cHL. Dose escalation cohorts will evaluate the safety, tolerability, PK, and preliminary efficacy in participants with r/r cHL.

Module 1 Part B optimization/expansion cohorts may be opened at selected dose levels. These cohorts will further characterise the safety, PK, and preliminary efficacy of AZD3470 to support dose optimization. Both adult and adolescent participants with r/r cHL will be eligible for this part of the study. Adolescent participants will only be enrolled once there is sufficient PK and safety data in adults. A preliminary effect of food on AZD3470 pharmacokinetics will be explored in this part of the study.

The protocol may be amended in the future to incorporate further expansion of cHL at the RP2D, additional monotherapy cohorts in other hematologic malignancies, and/or additional modules investigating AZD3470 in combination with other anticancer agents.

AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies.

A Modular Phase I/II, Open-label, Multicentre Study to Evaluate the Safety, Tolerability, and Efficacy of AZD3470, a PRMT5 Inhibitor, as Monotherapy and in Combination With Anticancer Agent(s) in Participants With Relapsed/Refractory Haematologic Malignancies

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

AEs: Number of patients with adverse events by system organ class and preferred term.

SAEs: Number of patients with serious adverse events by system organ class and preferred term.

In the Dose Escalation cohorts in Part A, the number of participants with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol

ORR is defined as the proportion of participants who have a CR or PR and CRR is defined as the proportion of participants who have a CR.

Assessment of ORR/CRR will be done according to the Lugano Classification for cHL.

The time from the date of first documented response until the date of documented progression as assessed by the investigator according to the Lugano classification for cHL, or death due to any cause

Time from date of first dose (non- randomised study parts) or date of randomization (randomised study parts) until progression as assessed by the investigator according to the Lugano Classification for cHL, or death due to any cause.

Time from date of first dose (non-randomised study parts) or date of randomization (randomised study parts) until the date of death due to any cause.

Assessed to characterize the plasma PK profile of AZD3470.

Assessed to characterize the urine PK profile of AZD3470.

Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion.

AstraZeneca

Symptoms and General Pathology

Recurrence

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

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

Cholangiocarcinoma

Glioblastoma

Bile Duct Cancer

Participants with MTAP-deleted solid tumors will receive escalating doses of TNG908 to estimate the MTD

Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG908 at the identified RP2D

Participants with MTAP-deleted mesothelioma will receive TNG908 at the identified RP2D

Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG908 at the identified RP2D

Participants with MTAP-deleted sarcoma (soft tissue and bone) will receive TNG908 at the identified RP2D

Participants with other MTAP-deleted solid tumors will receive TNG908 at the identified RP2D

Participants with MTAP-deleted relapsed/refractory glioblastoma will receive TNG908 at the identified RP2D

TNG908, a selective PRMT5 inhibitor, will be administered orally

TNG908

Tango Clinical Trials

Tim Cloughesy, MD

Nicholas Butowski, MD

Roger Stupp, MD

Ibiayi Dagogo-Jack, MD

Ugonma Chukwueke, MD

Angela Hirbe, MD, PhD

Mrinal Gounder, MD

David Spigel, MD

Jordi Rodon Ahnert, MD

Alex Spira, MD

Philippe Cassier, MD

Ludovic Doucet, MD

Capucine Baldini, MD

Ellen Hooper, MD

This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG908, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 192 participants.

This is a Phase 1/2 multi-center, open label study in solid tumor patients (including glioblastoma) who have a confirmed homozygous MTAP deletion in their tumor. The Phase 1 portion is a dose escalation study of oral TNG908 in patients with confirmed MTAP-deleted solid tumors. In Phase 2, 6 expansion arms defined by confirmed MTAP-deleted tumor types will enroll in parallel at the RP2D of TNG908. In both parts of the study participants who tolerate the drug may continue treatment until disease progression.

Phase 1 dose escalation (sequential) followed by phase 2 dose expansion in 6 arms (parallel)

Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG908 in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors

To determine the MTD and dosing schedule of TNG908

To assess anti-neoplastic activity of TNG908 in patients with MTAP-deleted advanced solid tumors by RECIST or mRECIST v1.1 or modified RANO criteria

To assess preliminary evidence of anti-neoplastic activity of TNG908 in patients with MTAP-deleted advanced solid tumors by RECIST or mRECIST v1.1or modified RANO criteria

To describe the safety and tolerability profile of TNG908 by frequency and severity of AEs

Area under the plasma concentration versus time curve (AUC)

Time to achieve maximal plasma concentration (Tmax)

Maximum observed plasma concentration (Cmax)

Apparent total plasma clearance when dosed orally (CL/F)

Apparent volume of distribution when dosed orally (Vz/F)

SDMA levels in tumor tissue will be assessed pre-treatment and post treatment with TNG908

Tango Therapeutics, Inc.

Participants with MTAP-deleted solid tumors (excluding primary CNS) will receive escalating doses of TNG462 to estimate the MTD

Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG462 at the identified RP2D

Participants with MTAP-deleted mesothelioma will receive TNG462 at the identified RP2D

Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG462 at the identified RP2D

Participants with MTAP-deleted sarcoma (soft tissue or bone) will receive TNG462 at the identified RP2D

Participants with other MTAP-deleted solid tumors will receive TNG462 at the identified RP2D

TNG462, a selective PRMT5 inhibitor, will be administered orally

TNG462

Christopher Chen

Jose Lutzky, MD

Candace Haddox, MD

Amy Weise, DO

Salman Punekar, MD

Ignacio Garrido-Iaguna, MD, PhD

Irene Brana, MD

Victor Moreno Garcia, MD

Emiliano Calvo Aller, MD

This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 159 participants.

This is a Phase 1/2 multi-center, open label study in solid tumor patients who have a confirmed homozygous MTAP deletion in their tumor. The Phase 1 portion is a dose escalation study of oral TNG462 in patients with confirmed MTAP-deleted solid tumors. In Phase 2, 5 expansion arms defined by confirmed MTAP-deleted tumor types will enroll in parallel at the RP2D of TNG462. In both parts of the study participants who tolerate the drug may continue treatment until disease progression.

Phase 1 dose escalation (sequential) followed by phase 2 dose expansion in 5 arms (parallel)

Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors

To determine the maximum tolerated dose (MTD) of TNG462

To determine the dosing schedule of TNG462

To assess anti-neoplastic activity of TNG462 in patients with MTAP-deleted advanced solid tumors by RECIST v1.1 or mRECIST v1.1

To assess preliminary evidence of anti-neoplastic activity of TNG462 in patients with MTAP-deleted advanced solid tumors by RECIST v1.1 or mRECIST v1.1

To describe the safety and tolerability profile of TNG462 by frequency and severity of AEs

Measure the area under the plasma concentration versus time curve (AUC)

Measure the time to achieve maximal plasma concentration (Tmax)

Measure the maximum observed plasma concentration (Cmax)

Determine the terminal elimination half-life (t1/2)

Determine the apparent total plasma clearance when dosed orally (CL/F)

Determine the apparent volume of distribution when dosed orally (Vz/F)

SDMA levels in tumor tissue will be assessed pre-treatment and post treatment with TNG462

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion	NCT05245500	Mesothelioma Non Small Cell ... Malignant Perip... Solid Tumor Pancreatic Aden... Advanced Solid ...	MRTX1719	18 Years -	Mirati Therapeutics Inc.
AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies.	NCT06137144	Lymphoma Non-Hodgkin Hodgkin Lymphom...	AZD3470	15 Years - 130 Years	AstraZeneca
A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas	NCT04089449	Advanced Solid ... Recurrent Gliom...	PRT811	18 Years -	Prelude Therapeutics
AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies.	NCT06137144	Lymphoma Non-Hodgkin Hodgkin Lymphom...	AZD3470	15 Years - 130 Years	AstraZeneca
Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors	NCT05275478	Locally Advance...	TNG908	18 Years -	Tango Therapeutics, Inc.
Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors	NCT05732831	Locally Advance...	TNG462	18 Years -	Tango Therapeutics, Inc.
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion	NCT04794699	Solid Tumor	IDE397 Docetaxel Paclitaxel Sacituzumab gov...	18 Years -	IDEAYA Biosciences
S095035 in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene	NCT06188702	MTAP-deleted So...	S095035	18 Years -	Servier
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

Every month we try and update this database with for prmt5 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 prmt5

Every month we try and update this database with for prmt5 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 prmt5 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.