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Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor

AMG 193 + Docetaxel for Advanced Solid Cancers (MTAP Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to swallow and retain orally administered study treatment and willing to record daily adherence to investigational product
Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights

MTAP Trial Summary

This trial is testing the safety and effectiveness of a new drug for adults with metastatic or locally advanced solid tumors. The drug will be given alone and in combination with another drug, and the trial will test different doses to find the best one. The trial will also test the drug in people with a specific type of lung cancer.

Who is the study for?
Adults over 18 with advanced solid tumors that can't be cured by surgery or radiation, specifically those without the MTAP gene. Participants must be able to take oral medication and have a life expectancy of at least 12 weeks. They should not have had certain prior treatments, active infections, heart issues, or other recent cancer therapies.Check my eligibility
What is being tested?
The trial is testing AMG 193 alone and combined with docetaxel in adults with MTAP-null solid tumors. It aims to find the safest dose for future studies (Parts 1 & 2) and measure how well the tumor responds to AMG 193 (Part 3).See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation, such as inflammation in various organs; typical chemotherapy-related effects like nausea, fatigue, hair loss; and possible blood disorders due to bone marrow suppression.

MTAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take pills and am willing to track my medication use.
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My cancer has spread and cannot be cured with surgery or radiation.
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My blood clotting levels are within a normal range.
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My cancer lacks certain genes (CDKN2A or MTAP) or the MTAP protein.
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My lungs are working well.
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I am fully active or can carry out light work.
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I am 18 years old or older.

MTAP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 3: Objective Response Rate (ORR)
Parts 1 and 2: Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
Parts 1 and 2: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Secondary outcome measures
Part 1a Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of AMG 193
Part 1a Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Comparator AMG 193 Test Tablet
Part 1a Only: Maximal Plasma Concentration (Cmax) of AMG 193
+23 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Aspartate aminotransferase increased
9%
Musculoskeletal pain
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Insomnia
6%
Transaminases increased
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

MTAP Trial Design

12Treatment groups
Experimental Treatment
Group I: Part 3: AMG 193 Phase 2Experimental Treatment1 Intervention
Participants with MTAP-null solid tumors will receive AMG 193.
Group II: Part 2b, Phase 1: AMG 193 + Docetaxel Dose ExpansionExperimental Treatment2 Interventions
Participants with MTAP-null NSCLC will receive the identified MTD/RP2D of AMG 193 + docetaxel.
Group III: Part 2a, Phase 1: AMG 193 Dose Exploration + DocetaxelExperimental Treatment2 Interventions
Participants with MTAP-null NSCLC will receive escalating doses of AMG 193 + a fixed dose of docetaxel to estimate the MTD/RP2D of the combination.
Group IV: Part 1k, Phase 1: AMG 193 Food Effect Substudy (US Sites Only)Experimental Treatment1 Intervention
Participants will receive AMG 193 once on a fasted state and once after eating a standardized high-fat, high calorie meal.
Group V: Part 1j, Phase 1: AMG 193 DSPS Substudy (US Sites Only)Experimental Treatment2 Interventions
Participants will receive doses of AMG 193 and comparator AMG 193 test tables at different times in a fasted state.
Group VI: Part 1i, Phase 1: AMG 193 Dose OptimizationExperimental Treatment1 Intervention
Participants will receive a randomized dose optimization evaluation of AMG 193.
Group VII: Part 1h, Phase 1: AMG 193 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null or lost MTAP expression solid tumors (other than lymphoma or primary brain tumor).
Group VIII: Part 1g, Phase 1: AMG 193 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null pancreatic adenocarcinoma
Group IX: Part 1f, Phase 1: AMG 193 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null head and neck squamous cell carcinoma (HNSCC)
Group X: Part 1e, Phase 1: AMG 193 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null BTC.
Group XI: Part 1c, Phase 1: AMG 193 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive the identified MTD/RP2D of AMG 193 in the following cohort: MTAP-null or lost MTAP expression NSCLC.
Group XII: Part 1a, Phase 1: AMG 193 Monotherapy Dose ExplorationExperimental Treatment2 Interventions
Participants with MTAP-null solid tumors will receive escalating doses of AMG 193 to estimate the MTD and/or the RP2D. A group of these participants in the United States (US) will have the option to take part in a Drug Substance Particle Size (DSPS) assessment. These participants will receive escalating doses of AMG 193 and a dose of a comparator AMG 193 test tablet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,355 Previous Clinical Trials
1,383,544 Total Patients Enrolled
MDStudy DirectorAmgen
899 Previous Clinical Trials
921,221 Total Patients Enrolled

Media Library

AMG 193 (Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05094336 — Phase 1 & 2
Solid Tumors Research Study Groups: Part 1j, Phase 1: AMG 193 DSPS Substudy (US Sites Only), Part 1k, Phase 1: AMG 193 Food Effect Substudy (US Sites Only), Part 1a, Phase 1: AMG 193 Monotherapy Dose Exploration, Part 1i, Phase 1: AMG 193 Dose Optimization, Part 2a, Phase 1: AMG 193 Dose Exploration + Docetaxel, Part 2b, Phase 1: AMG 193 + Docetaxel Dose Expansion, Part 3: AMG 193 Phase 2, Part 1h, Phase 1: AMG 193 Monotherapy Dose Expansion, Part 1c, Phase 1: AMG 193 Monotherapy Dose Expansion, Part 1e, Phase 1: AMG 193 Monotherapy Dose Expansion, Part 1g, Phase 1: AMG 193 Monotherapy Dose Expansion, Part 1f, Phase 1: AMG 193 Monotherapy Dose Expansion
Solid Tumors Clinical Trial 2023: AMG 193 Highlights & Side Effects. Trial Name: NCT05094336 — Phase 1 & 2
AMG 193 (Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05094336 — Phase 1 & 2
Solid Tumors Patient Testimony for trial: Trial Name: NCT05094336 — Phase 1 & 2

Frequently Asked Questions

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

What medical conditions is AMG 193 used to treat?

"AMG 193 is an effective intervention for patients with malignant neoplasms, advance directives, and sarcoma."

Answered by AI

What is the projected or estimated enrollment for this research project?

"In total, this study needs to enroll 340 patients that meet the basic requirements. For example, these individuals must be willing and able to travel to sites such as Duke University Medical Center or Community Health Network."

Answered by AI

What are the prerequisites for joining this clinical trial?

"This study requires that patients have advanced mtap-null solid tumors, be of legal age (18 years or older), and there are plans to recruit around 340 individuals in total."

Answered by AI

Can people with the qualifying condition participate in this research right now?

"Yes, the study is still recruiting patients. According to the clinicaltrials.gov website, this trial was posted on February 1st, 2022 and was last updated on October 26th, 2022. The study needs 340 patients from 7 different locations."

Answered by AI

Are people over the age of 45 who meet the other criteria for this research allowed to participate?

"This study is searching for test subjects that are at least 18 and not yet 100 years old."

Answered by AI

Could you please share what prior research has been conducted on AMG 193?

"As of now, there are 337 ongoing studies investigating AMG 193. Out of these, 132 are in Phase 3. Most trials for AMG 193 originate from Fuzhou, Fujian; however, there are 23091 locations conducting research on this topic."

Answered by AI

If a patient wanted to participate in this clinical trial, how many different places would they have to go?

"There are 7 medical centres currently enrolling patients for this trial, which include Duke University Medical Center, Community Health Network and Washington University. A full list of locations can be found below."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

This is the trial I am eligible for.
PatientReceived 1 prior treatment
~328 spots leftby Nov 2027