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Anti-tumor antibiotic

Subprotocol B: PDAC Arm B for 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Experiencing Dose Limiting Toxicities (DLT)

Number of Participants Experiencing Serious Adverse Events (SAE)

Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)

Secondary outcome measures

Area Under the Plasma Concentration-time Curve (AUC) of AMG 193

Disease Control (DC) per RECIST v1.1

Duration of Response (DOR) per RECIST v1.1

+6 more

Trial Design

3Treatment 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.

Group III: Subprotocol A: Biliary Tract Cancer (BTC)Experimental Treatment4 Interventions

Part 1: Participants with MTAP-deleted BTC will receive escalating doses of AMG 193 orally in combination with gemcitabine, cisplatin, and pembrolizumab intravenously (IV). Part 2: Participants with MTAP-deleted BTC will receive the recommended dose of AMG 193 in combination with gemcitabine, cisplatin, and pembrolizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Modified FOLFIRINOX

2011

Completed Phase 1

~20

Cisplatin

2013

Completed Phase 3

~1940

Gemcitabine

2017

Completed Phase 3

~2070

Nab-paclitaxel

2014

Completed Phase 3

~2030

Do I qualify?Apply below to find out

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Who is running the clinical trial?

AmgenLead Sponsor

1,380 Previous Clinical Trials

1,379,339 Total Patients Enrolled

MDStudy DirectorAmgen

925 Previous Clinical Trials

926,362 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age cutoff for participants in this study set at 45 years or older?

"Participants sought for this research must be over 18 years old but under 100 years of age."

Answered by AI

What are the specific criteria for eligibility to partake in this study?

"To qualify for participation in this clinical investigation, individuals must have a diagnosis of cancer and be aged between 18 to 100 years old. The study aims to enroll a total of 282 participants."

Answered by AI

Is the ongoing medical study actively seeking participants at this time?

"The trial, as documented on clinicaltrials.gov, is presently not in the recruitment phase. The trial was made public on May 1st, 2024 and last modified on April 8th, 2024. While this particular study is not accepting participants currently, there are a total of 606 other trials actively enrolling patients at present."

Answered by AI

What level of risk does Subprotocol A: Biliary Tract Cancer (BTC) pose to individuals participating in the trial?

"According to our evaluation at Power, the safety rating for Subprotocol A: Biliary Tract Cancer (BTC) is 1. This indicates that as a Phase 1 trial, there exists only minimal data supporting both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06360354.

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