A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)

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Trial Details

Sponsor: Amgen (industry)

Phase: 2

Start date: Dec. 26, 2024

Planned enrollment: 200

Last updated in HealthScout: Apr 2025

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chevron Show for: AMG 193 (AM-9747)

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Trial ID: NCT06593522
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More trial details at ClinicalTrials.gov More info

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Goal: The trial aims to evaluate the efficacy, safety, tolerability, and pharmacokinetics of two dose levels of AMG 193 in patients with MTAP-deleted advanced non-small cell lung cancer. The primary focus is on measuring the objective response according to RECIST 1.1 criteria, alongside several secondary outcomes.

Patients: The trial involves individuals diagnosed with advanced non-small cell lung cancer with MTAP deletions who have previously undergone and progressed after at least one systemic therapy for advanced disease. Eligible participants include those with resectable or unresectable conditions and those with treated or small untreated brain metastases.

Design: The study follows a randomized, two-part structure encompassing a dose evaluation followed by a dose expansion phase. A total of 200 participants will be enrolled and assigned to receive differing doses of AMG 193.

Treatments: AMG 193, an investigational drug and first-in-class oral PRMT5 inhibitor, is being evaluated. It operates on a synthetic lethal principle, selectively targeting MTA-cooperative PRMT5 in MTAP-deleted cells while sparing normal ones. Previous phase 1 trials demonstrated a 21.4% objective response rate in MTAP-deleted solid tumors, with the maximum tolerated dose at 1200 mg once daily. AMG 193 has shown promising initial results, particularly in lung, pancreatic, and biliary tract cancers.

Outcomes: The trial measures several outcomes, including the objective response rate assessed by both investigator and blinded independent central review, progression-free survival, duration of response, and overall survival over a 35-month timeframe. Additionally, pharmacokinetic parameters like maximum concentration (Cmax) and area under the curve (AUC) and quality of life assessments will be evaluated.

Burden on patient: The burden on patients may be moderate to high due to the requirement for frequent visits for pharmacokinetic blood draws, particularly in the initial cycles of treatment, alongside regular imaging assessments to evaluate tumor response. Additionally, patients need to comply with the dosing regimen and possible management of adverse effects, hence requiring consistent healthcare visits and coordination.

Eligibility Criteria More information

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GenesisCare -North Shore Oncology

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Mater Hospital Brisbane

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Núcleo de Oncologia da Bahia

Salvador, Bahia, 40170-110, Brazil

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Barretos, São Paulo, 14784-400, Brazil

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Mengchao Hepatobiliary hospital of Fujian Medical University

Fuzhou, Fujian, 350028, China

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The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

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Beijing Chest Hospital, Capital Medical University

Beijing, 101149, China

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Aichi Cancer Center

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The Cancer Institute Hospital of Japanese Foundation for Cancer Research

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Ajou University Hospital

Suwon-si Gyeonggi-do, 16499, Korea, Republic of

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Cha Bundang Medical Center, Cha University

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Singapore, 119074, Singapore

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Eastern Connecticut Hematology and Oncology Associates

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Cancer and Hematology Centers of Western Michigan

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United States Oncology Regulatory Affairs Corporate Office

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Sarah Cannon Research Institute Oncology Partners

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