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AMG 193 + Docetaxel for Advanced Solid Cancers (MTAP Trial)
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.
MTAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMTAP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT01301729MTAP Trial Design
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- I have previously been treated with docetaxel.I can take pills and am willing to track my medication use.My cancer has spread and cannot be cured with surgery or radiation.My liver is working well according to recent tests.My lungs are working well.My blood clotting levels are within a normal range.My cancer lacks certain genes or shows specific gene changes.My cancer lacks certain genes (CDKN2A or MTAP) or the MTAP protein.My heart is functioning well.My lungs are working well.I have had major surgery recently.I currently have an infection.I have had a blood clot in an artery before.I have not had radiation therapy in the last 2 weeks.I am willing to join a DSPS study in the US.I can eat a high-fat, high-calorie meal.I do not have spinal cord compression, untreated brain metastases, or leptomeningeal disease.I have had cancer other than my current diagnosis in the last 2 years.I have had a heart attack or symptoms of heart failure.I have been diagnosed with Congenital Short QT Syndrome.I am fully active or can carry out light work.I haven't had cancer treatment in the last 28 days, or it was a short-lived treatment.I am willing to have a tumor biopsy before and during treatment.I have had radiation to less than 25% of my bone marrow.I have not received a live vaccine in the last 4 weeks.I haven't taken strong CYP3A4 inducers in the last 14 days.I am 18 years old or older.I have not been treated with MAT2A or PRMT5 inhibitors before.I have a lung condition that affects the tissue and space around the air sacs.I have a disease affecting my digestive system.I am currently using blood thinners for a clotting issue.I am a woman able to have children but unwilling to use specified birth control methods.I can take pills and am willing to track my medication use.I have had issues like bowel blockage or serious gut infections.My cancer has spread and cannot be cured with surgery or radiation.I am willing to have a tumor biopsy for my head and neck cancer.I have had a solid organ transplant.I have lingering side effects from previous cancer treatments.My heart is functioning well.My kidney function is normal according to recent tests.I am 18 years old or older.The disease must be measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.You have provided informed consent/assent before any study specific activities/procedures.My cancer has spread and cannot be cured with surgery or radiation.
- Group 1: Part 1j, Phase 1: AMG 193 DSPS Substudy (US Sites Only)
- Group 2: Part 1k, Phase 1: AMG 193 Food Effect Substudy (US Sites Only)
- Group 3: Part 1a, Phase 1: AMG 193 Monotherapy Dose Exploration
- Group 4: Part 1i, Phase 1: AMG 193 Dose Optimization
- Group 5: Part 2a, Phase 1: AMG 193 Dose Exploration + Docetaxel
- Group 6: Part 2b, Phase 1: AMG 193 + Docetaxel Dose Expansion
- Group 7: Part 3: AMG 193 Phase 2
- Group 8: Part 1h, Phase 1: AMG 193 Monotherapy Dose Expansion
- Group 9: Part 1c, Phase 1: AMG 193 Monotherapy Dose Expansion
- Group 10: Part 1e, Phase 1: AMG 193 Monotherapy Dose Expansion
- Group 11: Part 1g, Phase 1: AMG 193 Monotherapy Dose Expansion
- Group 12: Part 1f, Phase 1: AMG 193 Monotherapy Dose Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What medical conditions is AMG 193 used to treat?
"AMG 193 is an effective intervention for patients with malignant neoplasms, advance directives, and sarcoma."
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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