Trial summary: This study aims to determine the maximum tolerated dose (MTD) or recommended combination dose of AMG 193 (PRMT5 inhibitor) when combined with other therapies in adults with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.
Status: OPEN - Recruiting
Trial identifier: NCT06360354
Sponsor: Amgen
Phase: I
Diagnosis: Locally advanced (Stage III) unresectable or Metastatic (Stage IV) pancreatic ductal adenocarcinoma
Line of therapy: First-line
Treatment: PRMT5 inhibitor AMG193 (oral) in combination with chemotherapy
  • Key inclusion criteria
    1. Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
    2. Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas.
    3. 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.
    4. Homozygous MTAP-deletion.
    5. Disease measurable as defined by RECIST v1.1.
    6. Adequate organ function as defined in the protocol.
  • Key exclusion criteria
    1. Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
    2. Radiation therapy within 28 days of first dose.
    3. Major surgery within 28 days of first dose of AMG 193.
    4. Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
    5. Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis).
    6. History of solid organ transplantation.

AMG193 20230223

Locations: Epworth Richmond, Epworth Freemasons (East Melbourne), Epworth Eastern (Box Hill).

Epworth PI: A/Prof Sumitra Ananda

Jreissati Pancreatic Centre at Epworth 

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