A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion
Purpose
The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult 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 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.
Condition
- Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A |
Part 1: Participants with MTAP-deleted PDAC will receive escalating doses of AMG 193 orally in combination with gemcitabine and nab-paclitaxel IV. Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of AMG 193 in combination with gemcitabine and nab-paclitaxel. |
|
|
Experimental Subprotocol B: PDAC Arm B |
Part 1: Participants with MTAP-deleted PDAC will receive escalating doses of AMG 193 orally in combination with mFOLFIRINOX (irinotecan, fluorouracil, leucovorin calcium, oxaliplatin) IV. Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of AMG 193 in combination with mFOLFIRINOX. |
|
Recruiting Locations
Bakersfield, California 93309
Duarte, California 91010
La Jolla, California 92093
Los Angeles, California 90095
Santa Monica, California 90404
Aurora, Colorado 80012
Hartford, Connecticut 06106
New Haven, Connecticut 06520
Norwalk, Connecticut 06856
Chicago, Illinois 60637
Indianapolis, Indiana 46202
Louisville, Kentucky 40202
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Saint Louis, Missouri 63110
Omaha, Nebraska 68198
Las Vegas, Nevada 89169
New York, New York 10065
Durham, North Carolina 27710
Cleveland, Ohio 44195
Nashville, Tennessee 37203
Houston, Texas 77030
Irving, Texas 75063
Charlottesville, Virginia 22903
Fairfax, Virginia 22031
Tacoma, Washington 98405
Vancouver, Washington 98684
More Details
- NCT ID
- NCT06360354
- Status
- Recruiting
- Sponsor
- Amgen