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Clinical Trials List

Protocol Number20230153
NCT Number(ClinicalTrials.gov Identfier)NCT06593522
Active

2024-09-24 - 2029-12-31

Phase II

Recruiting3

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/06/17

Investigators and Locations

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

MTAP-deleted NSCLC

Objectives

This is a phase 2, multicenter, open-label trial evaluating the efficacy, safety, tolerability, and pharmacokinetics (PK) of AMG 193 in patients with methionine phosphorylase (MTAP)-deficient non-small cell lung cancer (NSCLC) who have progressed or relapsed after platinum-based chemotherapy and checkpoint inhibitor therapy. The trial was conducted in two parts. Part 1 aimed to evaluate two doses of AMG 193. Part 2 aimed to further evaluate AMG 193 at selected dose levels. Assessment Metrics Primary (Part 1 only): For randomization dose selection only • Describe the safety and efficacy of the two doses of AMG 193 (as assessed by the trial administrator) Primary (Parts 1 and 2) • Assess the efficacy of AMG 193 monotherapy, determined by a blinded central independent review committee (BICR) Secondary (Parts 1 and 2) • Other measures assessing the antitumor activity of AMG 193, determined by the BICR • Other measures assessing the antitumor activity of AMG 193, determined by the trial administrator • Assess overall survival (OS) • Assess the safety and tolerability of AMG 193 • Assess the pharmacokinetics of AMG 193 • Explore participants' experiences with AMG 193 treatment using the participant self-report outcome tool

Test Drug

Tablets

Active Ingredient

AMG 193

Dosage Form

110

Dosage

200 mg

Endpoints

-

Inclution Criteria

Inclusion Criteria:

Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP) NSCLC
Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
Either an archival tissue sample or an archival block must be available.
Life expectancy of greater than 3 months, in the opinion of the investigator.
Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.
Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible.

Exclusion Criteria

Exclusion Criteria:

Disease Related

• Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2/ERBB2), KRAS proto-oncogene G12C (KRAS G12C).

Other Medical Conditions

Major surgery within 28 days of study day 1.
Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.

The Estimated Number of Participants

  • Taiwan

    12 participants

  • Global

    200 participants

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