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Clinical Trials List

Protocol Number20230223
NCT Number(ClinicalTrials.gov Identfier)NCT06360354
Active

2024-09-02 - 2027-12-31

Phase I

Recruiting3

ICD-10C25.3

Malignant neoplasm of pancreatic duct

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9157.3

Malignant neoplasm of pancreatic duct

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 in Combination With Other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/03/01

Investigators and Locations

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Ping Hung Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers

Objectives

This trial aims to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of AMG 193 (a methionine (MTA) co-protein arginine methyltransferase 5 (PRMT5) inhibitor) in combination with other therapies in patients with advanced homozygous MTAP-deficient gastrointestinal, cholangiocarcinoma, or pancreatic cancer. The theoretical basis for the investigational dosing regimen is detailed in the corresponding sub-trial protocol.

Test Drug

錠劑

Active Ingredient

AMG 193

Dosage Form

110

Dosage

100 200 mg

Endpoints

• Determine the maximum tolerated dose (MTD) or recommended dose of AMG 193 in combination with other therapies in adult subjects with metastatic or locally advanced MTAP-deficient gastrointestinal, cholangiocarcinoma, or pancreatic cancer.
• Dose-limiting toxicities (DLTs), treatment-related adverse events, serious adverse events, and changes in vital signs, electrocardiogram (ECG), and clinical laboratory tests.

• Determine the safety profile of AMG 193 in combination with other therapies in adult subjects with metastatic or locally advanced MTAP-deficient gastrointestinal, cholangiocarcinoma, or pancreatic cancer.
• Treatment-related adverse events, serious adverse events, and changes in vital signs, ECG, and clinical laboratory tests.

Inclution Criteria

Inclusion:

Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas.
Tumor tissue (FFPE sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before dosing.
Homozygous MTAP-deletion.
Disease measurable as defined by RECIST v1.1.
Adequate organ function as defined in the protocol.

Exclusion Criteria

Exclusion:

Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
Radiation therapy within 28 days of first dose.
Major surgery within 28 days of first dose of AMG 193.
Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
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).
History of solid organ transplantation.

The Estimated Number of Participants

  • Taiwan

    9 participants

  • Global

    282 participants

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