A Study Evaluating Anvumetostat in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (MTAPESTRY 103) - Master Protocol Anvumetostat in Combination with mFOLFIRINOX or with Gemcitabine and Nab-paclitaxel in Subjects with Advanced PDAC with Homozygous MTAP-deletion (Subprotocol B)

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 - Master Protocol A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Anvumetostat in Combination with mFOLFIRINOX or with Gemcitabine and Nab-paclitaxel in Subjects with Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) with Homozygous MTAP-deletion (Subprotocol B)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240376

Enrollment

350

Registered

2024-10-07

Start date

2024-05-29

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancers

Interventions

- Experimental: Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A Part 1: Participants with MTAP-deleted PDAC will receive doses of Anvumetostat orally in combination with gemcitabine and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subprotocol B 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

Exclusion criteria

Exclusion criteria: Subprotocol B 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 Anvumetostat. 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 (eg, Crohn's disease, ulcerative colitis). 6. History of solid organ transplantation.

Design outcomes

Primary

Measure	Time frame
1. Number of Participants Experiencing Dose Limiting Toxicities (DLT) [Time Frame: Up to 28 days] 2. Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) [Time Frame: Up to approximately 2 years] Any clinically significant changes in vital signs, electrocardiogram, or lab parameters will be recorded as TEAEs. 3. Number of Participants Experiencing Serious Adverse Events (SAE) [Time Frame: Up to approximately 2 years]	—

Measure

Time frame

1. Number of Participants Experiencing Dose Limiting Toxicities (DLT) [Time Frame: Up to 28 days] 2. Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) [Time Frame: Up to approximately 2 years] Any clinically significant changes in vital signs, electrocardiogram, or lab parameters will be recorded as TEAEs. 3. Number of Participants Experiencing Serious Adverse Events (SAE) [Time Frame: Up to approximately 2 years]

—

Secondary

Measure	Time frame
1. Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [Time Frame: Up to approximately 2 years] 2. Disease Control (DC) per RECIST v1.1 [Time Frame: Up to approximately 2 years] 3. Duration of Response (DOR) per RECIST v1.1 [Time Frame: Up to approximately 2 years] 4. Time to Response (TTR) per RECIST v1.1 [Time Frame: Up to approximately 2 years] 5. Overall Survival (OS) per RECIST v1.1 [Time Frame: Up to approximately 2 years] 6. Progression-free Survival (PFS) per RECIST v1.1 [Time Frame: Up to approximately 2 years] 7. Maximum Plasma Concentration (Cmax) of Anvumetostat [Time Frame: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)] 8. Time to Maximum Plasma Concentration (tmax) of Anvumetostat [Time Frame: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)] 9. Area Under the Plasma Concentration-time Curve (AUC) of Anvumetostat [Time Frame: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)]	—

Measure

Time frame

1. Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [Time Frame: Up to approximately 2 years] 2. Disease Control (DC) per RECIST v1.1 [Time Frame: Up to approximately 2 years] 3. Duration of Response (DOR) per RECIST v1.1 [Time Frame: Up to approximately 2 years] 4. Time to Response (TTR) per RECIST v1.1 [Time Frame: Up to approximately 2 years] 5. Overall Survival (OS) per RECIST v1.1 [Time Frame: Up to approximately 2 years] 6. Progression-free Survival (PFS) per RECIST v1.1 [Time Frame: Up to approximately 2 years] 7. Maximum Plasma Concentration (Cmax) of Anvumetostat [Time Frame: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)] 8. Time to Maximum Plasma Concentration (tmax) of Anvumetostat [Time Frame: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)] 9. Area Under the Plasma Concentration-time Curve (AUC) of Anvumetostat [Time Frame: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)]

—

Countries

Australia, Belgium, Canada, China, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan, Netherlands, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactContact Local

Amgen K.K.

clinicaltrials_japan@amgen.com+81-80-7217-8592

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026