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PC14586 for Solid Tumors
Study Summary
This trial will investigate if a new drug is safe and effective for treating people with solid tumors that have a TP53 Y220C mutation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- My brain metastases are stable without needing steroids for symptoms.I am 18 years or older, or between 12 to 17 years with adult safety data available.I do not have recent severe heart problems or uncontrolled blood pressure.My cancer started in the brain or spinal cord.I have cancer, but it's not skin cancer or treated cervical issues.I am not taking strong CYP3A4 drugs, QT prolonging medications, or proton pump inhibitors.I have not had a stroke or mini-stroke in the last 6 months.My organs are working well.I have a stomach or intestine condition that affects medication absorption.My cancer has worsened despite previous treatments.My cancer has a specific TP53 mutation.I am fully active or restricted in physically strenuous activity but can do light work.I have had spinal cord compression or cancer spread to the lining of my brain.I have not had radiotherapy in the last 28 days.I haven't had cancer treatment in the last 21 days or 5 half-lives before starting the study drug.I have had an organ transplant in the past.I do not have active, uncontrolled Hepatitis B, C, or HIV.
- Group 1: Phase 1 Monotherapy Dose Escalation
- Group 2: Phase 1b Combination Therapy Dose Expansion, PD(L)-1 naive patients
- Group 3: Phase 2 Monotherapy Dose Expansion, Ovarian Cancer Cohort
- Group 4: Phase 2 Monotherapy Dose Expansion, Lung Cancer Cohort
- Group 5: Phase 1b Combination Therapy Dose Escalation, Part 1
- Group 6: Phase 2 Monotherapy Dose Expansion, Breast Cancer Cohort
- Group 7: Phase 2 Monotherapy Dose Expansion, Other Solid Tumors Cohort
- Group 8: Phase 1b Combination Therapy Dose Expansion, PD(L)-1 relapsed/refractory patients
- Group 9: Phase 2 Monotherapy Dose Expansion, Endometrial Cancer Cohort
- 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
In what number of venues is this experiment currently taking place?
"Currently, 12 sites are administering this trial. These locations span from Nashville to Austin and include several other cities in between. For your convenience, you should select the closest location to avoid extensive travel if you decide to partake."
Are there any vacancies open to join this clinical experiment?
"Correct. The clinicaltrials.gov website indicates that this medical study, which was initially published on October 29th 2020, is actively recruiting participants. A total of 145 patients need to be recruited from 12 different sites."
What is the participant capacity of this trial?
"In order to begin the trial, 145 eligible participants need to be enrolled. PMV Pharmaceuticals is managing this research through multiple sites such as Sarah Cannon and HCA Research Institute in Nashville, Tennessee and Memorial Sloan Kettering in New york City."
What is the ultimate purpose of this investigative project?
"This medical trial has a duration of 48 months, over the course of which two primary outcomes will be assessed: (1) document and classify any adverse effects caused by PC14586; and (2) measure the response rate to evaluate efficacy using RECIST v. 1.1 criteria. Additionally, secondary objectives include gauging changes in quality of life through validated instruments for participants 18 years or older, measuring progression free survival/overall survival rates with RECIST v. 1.1 standards, and assessing preliminary clinical activity / efficacy utilising ORR metrics as well as other response rate assessments."
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