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 Anvumetostat in Combination With Other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/06/17
Investigators and Locations
Co-Principal Investigator
- Ming-Huang Chen Division of Hematology & Oncology
- Shao-Jung Hsu Division of General Internal Medicine
- 姜乃榕 Division of Hematology & Oncology
- Chien-An Liu Division of Radiology
- I-Cheng Lee Division of General Internal Medicine
- San-Chi Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 呂理駿 Division of Hematology & Oncology
- 莊建淮 Division of Hematology & Oncology
- YU-YUN SHAO Division of Hematology & Oncology
- SHIH-HUNG YANG Division of Hematology & Oncology
- 郭弘揚 Division of Hematology & Oncology
- TSUNG-HAO LIU Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chia-Jui Yen
Co-Principal Investigator
- Yan-Shen Shan Division of Hematology & Oncology
- Chien-Jui Huang Division of Hematology & Oncology
- Chih-Chieh Yen Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
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
Tablets
Active Ingredient
AMG 193
Dosage Form
110
Dosage
100 200 mg
Endpoints
Primary Objectives:
**Determine the maximum tolerated dose (MTD) or recommended dose of AMG 193 in combination with gemcitabine and nab-paclitaxel or in combination with mFOLFIRINOX for adult subjects with locally advanced or metastatic MTAP-deficient pancreatic ductal adenocarcinoma (PDAC).
**Determine the safety profile of AMG 193 in combination with gemcitabine and nab-paclitaxel or in combination with mFOLFIRINOX for adult subjects with locally advanced or metastatic MTAP-deficient PDAC.**
Secondary Objectives:
**Evaluate the antitumor activity of AMG 193 in combination with gemcitabine and nab-paclitaxel or in combination with mFOLFIRINOX for adult subjects with locally advanced or metastatic MTAP-deficient PDAC.**
**Investigate the effects of AMG 193 in combination with gemcitabine and nab-paclitaxel or in combination with mFOLFIRINOX.** Pharmacokinetic (PK) characteristics of mFOLFIRINOX in adult subjects with locally advanced or metastatic MTAP-deficient PDAC.
**Determine the maximum tolerated dose (MTD) or recommended dose of AMG 193 in combination with gemcitabine and nab-paclitaxel or in combination with mFOLFIRINOX for adult subjects with locally advanced or metastatic MTAP-deficient pancreatic ductal adenocarcinoma (PDAC).
**Determine the safety profile of AMG 193 in combination with gemcitabine and nab-paclitaxel or in combination with mFOLFIRINOX for adult subjects with locally advanced or metastatic MTAP-deficient PDAC.**
Secondary Objectives:
**Evaluate the antitumor activity of AMG 193 in combination with gemcitabine and nab-paclitaxel or in combination with mFOLFIRINOX for adult subjects with locally advanced or metastatic MTAP-deficient PDAC.**
**Investigate the effects of AMG 193 in combination with gemcitabine and nab-paclitaxel or in combination with mFOLFIRINOX.** Pharmacokinetic (PK) characteristics of mFOLFIRINOX in adult subjects with locally advanced or metastatic MTAP-deficient PDAC.
Inclution Criteria
Subprotocol B
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.
Subprotocol C
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.
Homozygous MTAP-deletion.
Rat Sarcoma Viral Oncogene Homolog (RAS) mutation
Received at least 1 prior systemic therapy for advanced or metastatic PDAC.
Disease measurable as defined by RECIST v1.1.
Adequate organ function as defined in the protocol.
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.
Subprotocol C
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.
Homozygous MTAP-deletion.
Rat Sarcoma Viral Oncogene Homolog (RAS) mutation
Received at least 1 prior systemic therapy for advanced or metastatic PDAC.
Disease measurable as defined by RECIST v1.1.
Adequate organ function as defined in the protocol.
Exclusion Criteria
Subprotocol B
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 Anvumetostat.
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.
Subprotocol C
Exclusion:
Prior treatment with aMAT2A inhibitor, a PRMT5 inhibitor, or a MAPK pathway inhibitor, including KRAS inhibitors.
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.
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 Anvumetostat.
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.
Subprotocol C
Exclusion:
Prior treatment with aMAT2A inhibitor, a PRMT5 inhibitor, or a MAPK pathway inhibitor, including KRAS inhibitors.
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
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Taiwan
9 participants
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Global
282 participants
