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RecruitingLast updated: 19 November 2024

AMG193 20230223: This study will evaluate targeted therapy in combination with chemotherapy in participants with advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers.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 purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Trial acronym

AMG193 20230223

Clinical summary

Summary

Please note, Austin Health and Epworth Jreissati Pancreatic Centre is currently only recruiting patients with pancreatic cancer to this trial.

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of a targeted therapy (AMG 193) in combination with chemotherapy in participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers.

The study also aims to determine the safety profile of AMG 193.

Participants in this interventional study will be allocated into one of two arms:

Arm A Part 1: Participants will recieve an escalating dose of AMG 193 orally in combination with chemotherapy (gemcitabine and nab-paclitaxel, administered via IV infusion).

Arm A Part 2: Participants will receive the recommended dose of AMG 193 orally in combination with chemotherapy (gemcitabine and nab-paclitaxel, administered via IV infusion).

Arm B Part 1: Participants will receive escalating doses of AMG 193 orally in combination with mFOLFIRINOX chemotherapy (irinotecan, fluorouracil, leucovorin calcium, oxaliplatin - administered via IV infusion.) 

Arm B Part 2:Participants will receive the recommended dose of AMG 193 orally in combination with mFOLFIRINOX chemotherapy (administered via IV infusion).

Conditions

This trial is treating people with advanced gastrointestinal, biliary bract, or pancreatic cancers

Eligibility

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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Amgen

Scientific Title

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

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