Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Participants will receive escalating doses of AMG 193 and IDE397 administered orally (PO) in cycles of 21 days.

AMG 193 and IDE397 will be administered PO in cycles of 21 days.

AMG 193

IDE397

Amgen Call Center

The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of AMG 193 in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of AMG 193 in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).

A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors

A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors

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

Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events

Amgen

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Sacituzumab govitecan

Tubulin Modulators

Antimitotic Agents

Immunoconjugates

Immunologic Factors

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors	NCT05975073	MTAP-null Non-S... MTAP-null Solid...	AMG 193 IDE397	18 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

Spots Global Cancer Trial Database for ide397

Every month we try and update this database with for ide397 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 ide397

Every month we try and update this database with for ide397 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 ide397 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.