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Anti-tumor antibiotic

AMG 193 + Other Therapies for Pancreatic Cancer

Phase 1
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights

Summary

This trial aims to find the highest safe dose of a drug called AMG 193 when given with other treatments to adults with certain types of advanced gastrointestinal, biliary tract, or pancreatic cancers. The

Who is the study for?
This trial is for adults with advanced gastrointestinal, biliary tract, or pancreatic cancers that have a specific genetic deletion (MTAP-deletion). Participants should be able to receive chemotherapy and must not have had certain treatments before. Full eligibility depends on additional criteria not provided here.
What is being tested?
The study tests the highest dose of AMG 193 that's safe when given with other cancer therapies like Cisplatin, Gemcitabine, Modified FOLFIRINOX, Nab-paclitaxel, and Pembrolizumab in patients with MTAP-deleted cancers.
What are the potential side effects?
Possible side effects include reactions to the drug infusion, nausea from chemotherapy drugs like Cisplatin and Gemcitabine, nerve damage from Nab-paclitaxel, immune-related effects from Pembrolizumab. The exact side effects of AMG 193 are being studied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm AExperimental Treatment3 Interventions
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.
Group II: Subprotocol B: PDAC Arm BExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Modified FOLFIRINOX
2011
Completed Phase 1
~20
Gemcitabine
2017
Completed Phase 3
~1920
Nab-paclitaxel
2014
Completed Phase 3
~1950

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,420 Previous Clinical Trials
1,382,762 Total Patients Enrolled
MDStudy DirectorAmgen
961 Previous Clinical Trials
928,677 Total Patients Enrolled
~125 spots leftby Nov 2025
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