Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Mesothelioma

Mesothelioma, Malignant

Nerve Sheath Neoplasms

Neurofibrosarcoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenoma

Neoplasms, Mesothelial

Pleural Neoplasms

Neoplasms, Nerve Tissue

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Peripheral Nervous System Diseases

Neuromuscular Diseases

Fibrosarcoma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Neurofibromatoses

Neurofibroma

Pancreatic Cancer

Malignant Mesothelioma

Malignant Peripheral Nerve Sheath Tumor

Soft Tissue Sarcoma

Neurofibromatosis

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

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Antineoplastic Agents

Paclitaxel

Gemcitabine

Docetaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

AG-270 will be administered on Days 1 to 28 of each 28-day cycle. Treatment will continue until disease progression or unacceptable toxicity.

AG-270 will be administered daily, starting 1 week prior to docetaxel infusion. Starting on Cycle 1 Day 1, docetaxel (by intravenous infusion \[IV\]) will be administered once during each 21-day cycle. Treatment with AG-270 and docetaxel will continue until disease progression or unacceptable toxicity.

AG-270 will be administered daily, starting 1 week prior to nab-paclitaxel and gemcitabine infusion. Starting on Cycle 1 Day 1, nab-paclitaxel and gemcitabine IV will be administered on Days 1,8, and 15 during each 28-day cycle. Treatment with AG-270, nab-paclitaxel, and gemcitabine will continue until disease progression or unacceptable toxicity.

AG-270, orally, once or twice daily, on Days 1 through 28 of each 28-day cycle, until disease progression or unacceptable toxicity.

AG-270

AG-270, orally, once or twice daily, for 1 week prior to the first dose of docetaxel. Thereafter, AG-270 continues to be given daily, on Days 1 through 21 of each 21-day cycle, until disease progression or unacceptable toxicity.

AG-270, orally, once or twice daily for 1 week prior to the first doses of nab-paclitaxel and gemcitabine. Thereafter, AG-270 continues to be given daily on Days 1 through 28 of each 28-day cycle, until disease progression or unacceptable toxicity.

Docetaxel, IV, once during each 21-day cycle, until disease progression or unacceptable toxicity.

docetaxel

Nab-paclitaxel, IV, on Days 1, 8, and 15 of each 28-day cycle, until disease progression or unacceptable toxicity.

nab-paclitaxel

Gemcitabine, IV, on Days 1, 8, and 15 of each 28-day cycle, until disease progression or unacceptable toxicity.

gemcitabine

This study will evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of AG-270 in participants with advanced solid tumors or lymphoma with homozygous MTAP deletion.

The purpose of this Phase 1, multicenter, open-label study is to determine the maximum tolerated dose (MTD) of AG-270, administered as a single agent or in combination with taxane-based chemotherapy, and to characterize its dose-limiting toxicities (DLTs) when given daily by mouth to participants with advanced solid tumors or lymphoma with homozygous deletion of methylthioadenosine phosphorylase (MTAP).

In each arm of the study, successive cohorts of participants will receive increasing oral doses of AG-270 to determine the MTD, the dose with maximum pharmacologic activity or the maximum feasible dose, as a single agent and in combination with taxane-based chemotherapy. In the subsequent dose-expansion parts of the study, additional participants in each treatment arm will be treated at the MTD (or one of the described alternative doses) to further characterize that dose's safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and to detect preliminary evidence of anti-tumor activity.

Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss

A Phase 1 Study of AG-270 in the Treatment of Subjects With Advanced Solid Tumors or Lymphoma With Homozygous Deletion of MTAP

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

* sponsored by Servier
* with a first patient enrolled as of 1 January 2004 onwards
* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Institut de Recherches Internationales Servier

Micronutrients

Hematinics

Vitamins

Pembrolizumab

Carboplatin

Pemetrexed

Sotorasib

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.

Amgen

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Sacituzumab govitecan

Immunoconjugates

Immunologic Factors

IDE397

IDEAYA Clinical Trials

Maroof Khan Zafar

New Patient Services

Teresa Lund

Estefania Bobe Cortes

Heather Flynn

Carol Goldener

Kailene Sullivan

Brandon Smith

Benjamin Herzberg, MD

Alexandra Mavracick

Christina Seunath

Benedito Carneiro

askSARAH

Jordi Rodon, MD

Carmen Gonzalez

Jia Liu

Ganessan Kichenadasse

Antoine Italiano

Eulalie Magne

Laurent Greillier

Thibault De la Motte Rouge

Frank Knauer

Ki Hyeong Lee

Ji-Youn Han

Joo-Hang Kim

Hye Ryun Kim

Changmin Choi

Montserrat Pequera Juvany

Elisa Lorente

Marta Benitez

Jorge Mercado

Laura Bailach

Ya-Zong Hsu

Chia-Chi Lin

Jasgit Sachdev, MD

This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with other anticancer agents including taxanes (docetaxel, paclitaxel), or sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).

Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors

Incidence of DLTs of IDE397 will be determined

Incidence of DLTs of IDE397 in a combination setting will be determined

MTD and RP2D of IDE397 will be determined

MTD and RP2D of IDE397 in a combination setting will be determined

Objective Response Rate (ORR) and Duration of Response (DoR)

Pharmacokinetics of IDE397 and metabolite following single and multiple oral administration as a single agent and in combination with docetaxel or paclitaxel or sacituzumab govitecan, will be determined

Pharmacokinetics of docetaxel or paclitaxel or sacituzumab govitecan.

Changes in the levels of MAT2A pathway and PRMT5 pathway will be determined

Objective response rate and duration of response will be assessed by Investigator using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

IDEAYA Biosciences

S095035 will be taken orally once daily in 28-day cycle.

S095035

Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department

This is a first-in-human Phase 1, multicenter, open-label dose escalation study of S095035 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have failed to respond to or have progressed after at least 1 prior treatment regimen, and for whom additional effective standard treatment is not available. S095035 is an oral methionine adenosyltransferase 2A \[MAT2A\] inhibitor.

S095035 in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene

A Phase 1, Open-label, Multicenter Clinical Trial of S095035 (MAT2A Inhibitor) in Adult Participants With Advanced or Metastatic Solid Tumors With Homozygous Deletion of MTAP

Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per the investigator's assessment

CBR=complete response \[CR\]+partial response \[PR\]+stable disease \[SD\] ) ≥6 months, Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per the investigator's assessment

Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per the investigator's assessment. The time from date of first documented confirmed CR or confirmed PR to date of first documented disease progression or death due to any cause.

Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per the investigator's assessment. The time from the date of randomization to date of first documented confirmed complete response (CR) or confirmed partial response (PR).

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.
Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss	NCT03435250	Advanced Solid ... Lymphoma	AG-270 AG-270 AG-270 docetaxel nab-paclitaxel gemcitabine	18 Years -	Servier
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
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion	NCT04794699	Solid Tumor	IDE397 Docetaxel Paclitaxel Sacituzumab gov...	18 Years -	IDEAYA Biosciences
Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss	NCT03435250	Advanced Solid ... Lymphoma	AG-270 AG-270 AG-270 docetaxel nab-paclitaxel gemcitabine	18 Years -	Servier
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

Spots Global Cancer Trial Database for mtap

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

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