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PY159 + Pembrolizumab for Advanced Cancers
Study Summary
This trial is testing a new drug to see if it is safe and effective in treating cancer that has spread or come back after other treatments.
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.Trial Design
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Who is running the clinical trial?
Media Library
- I have an advanced solid tumor of a specific type.I haven't had severe heart issues or angina in the last year.I haven't had cancer treatment in the last 3 weeks, but I'm on LHRH for prostate cancer without spread.You need to give a sample of your tumor for testing TREM1 expression.My brain metastases are stable and have been for at least 1 month.I do not have any severe illnesses like COVID-19 or conditions that could interfere with the study.I have severe liver disease with symptoms like confusion or bleeding problems.I am eligible for treatment targeting specific genes or proteins in my cancer.I am 18 years old or older.I have an autoimmune disorder but it's not thyroid disease, or my thyroid disease is well-controlled with medication.My cancer has worsened after treatment with immunotherapy.You have a disease that can be measured using a specific method called RECIST 1.1.I can take care of myself but might not be able to do heavy physical work.All side effects from my previous cancer treatments are mild now.My solid tumor diagnosis was confirmed through testing.
- Group 1: Part A: PY159 Single agent dose level 2
- Group 2: Part A: PY159/Pembrolizumab Combination dose level 1
- Group 3: PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 4
- Group 4: Part A: PY159 Single agent dose level 1
- Group 5: Part A: PY159 single agent dose level 5
- Group 6: PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 2
- Group 7: Part A: PY159/Pembrolizumab Combination dose level 2
- Group 8: Part A: PY159/Pembrolizumab Combination dose level 4
- Group 9: Part A: PY159 single agent dose level 4
- Group 10: PY159 Part B: Single agent dose expansion cohort(s)
- Group 11: Part A: PY159/Pembrolizumab Combination dose level 3
- Group 12: Part A: PY159 single agent dose level 3
- Group 13: PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 3
- Group 14: Part A: PY159 single agent dose level 7
- Group 15: Part A: PY159 single agent dose level 6
- Group 16: PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 1
- Group 17: PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 5
- Group 18: PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 6
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 prior studies have been conducted to explore the effects of a PY159/Pembrolizumab combination dosage?
"Presently, 961 clinical trials are being conducted to further research PY159/Pembrolizumab Combination dose expansion cohorts. Of those ongoing studies, 122 have progressed to phase 3 and originate from the Houston area; however, this treatment is also undergoing study in 35742 other medical centres worldwide."
Are enrollment opportunities still available for those wishing to take part in the trial?
"Affirmative. According to the information listed on clinicaltrials.gov, this medical trial is actively recruiting individuals and was initially posted in November of 2020. The most recent update occurred on 3rd November 2022, with 343 participants needed from 12 different sites."
In how many locations is this clinical trial being conducted?
"Currently, this medical trial is registering patients in 12 cities across the United States. These cities include San Francisco, Sarasota and Norman as well as nine other locations. To reduce travel costs associated with participation, we recommend considering a clinic that is located near you."
What conditions are targeted by the PY159/Pembrolizumab Combination dose expansion cohorts?
"The PY159/Pembrolizumab Combination dose expansion cohorts is often utilized to treat malignant neoplasms and can be beneficial for patients with unresectable melanoma, microsatellite instability high, or those whose disease has progressed after chemotherapy."
What implications does the PY159/Pembrolizumab Combination dose expansion cohorts have for human health?
"Based on our team's assessment, the PY159/Pembrolizumab Combination dose expansion cohorts has a safety rating of 1. This is due to this Phase 1 trial only having preliminary data regarding efficacy and safety."
How many people are enlisted in this research investigation?
"That is correct. According to details posted on clinicaltrials.gov, this medical trial which was initially made available in November of 2020, is currently recruiting a total of 343 individuals from 12 centres."
What aims is this clinical trial trying to accomplish?
"As per the trial's sponsor, Gilead Sciences,the primary efficacy endpoint is Dose Limiting Toxicity of PY159 and will be analysed over a 36 month period. Additionally, secondary endpoints such as maximum concentration (Cmax), area under curve (AUC)0-t, and volume at steady state (Vss) shall be evaluated for all participants receiving PY159 who have measured concentrations post dosing commencement."
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