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

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

NCT05975073•Amgen

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Evidence of homozygous loss of MTAP (null) and/or MTAP deletion.
•2. Presence of advanced/metastatic solid tumor not amenable to curative treatment
•1. Part 1: MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists
•2. Part 2: MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy.
•3. Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product
•4. Disease measurable as defined by RECIST v1.1
•5. Adequate organ function as defined in the protocol.
•6. Archived tumor tissue. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before cycle 1 day 1 dosing.

Exclusion Criteria

•1. Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
•2. Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease.
•4. Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis)
•5. History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry.
•6. Prior irradiation to \> 25% of the bone marrow
•7. Use of prescription medications that are known strong CYP3A4/5 inducers or strong CYP3A4/5 inhibitors within 7 days for CYP3A4/5 inhibitors, 14 days for CYP3A4/5 inducers or 5 half-lives, whichever is longer, prior to any dose of investigational medical product.

Locations (27)

City of Hope National Medical Center

Duarte, California, United States

Sarah Cannon Research Institute

Denver, Colorado, United States

Community Health Network MD Anderson Cancer Center - North

Indianapolis, Indiana, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Health Partners Cancer Center at Regions Hospital

Saint Paul, Minnesota, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

New York University Grossman School of Medicine and New York University Langone Hospitals

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

August 1, 2023

Primary Completion Date

April 1, 2026

Completion Date

April 1, 2026

Last Updated

December 23, 2025

Enrollment

ACTUAL participants

Conditions

MTAP-null Non-Small-Cell Lung CancerMTAP-null Solid Tumors

Interventions

AMG 193

DRUG

IDE397

DRUG