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TPST-1495 + Pembrolizumab for Cancer
Study Summary
This trial is testing a new drug, TPST-1495, to see if it is safe and effective in treating subjects with advanced solid tumors. The study will also look at the side effects of the drug and how it works in the body.
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 organs and bone marrow work well, and I haven't had transfusions or growth support in the last month.My liver enzymes are within the required limits.My tumor is at least 1 cm big and can be seen on a scan.I had a stomach ulcer over a year ago or treated my H. pylori infection.I am fully active or restricted in physically strenuous activity but can do light work.I haven't needed systemic treatment for an autoimmune or inflammatory disorder in the last 2 years.I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.I haven't had any cancer treatment with antibodies or chemotherapy in the last 4 weeks.I haven't taken any experimental drugs recently.I do not have HIV, active Hepatitis B or C, and am not on antiviral therapy for these conditions.I do not have any serious ongoing illnesses that could affect my participation in the study.I have not received any cancer treatments recently.My cancer cannot be surgically removed, has spread, and standard treatments have failed.I haven't taken any TKI cancer drugs in the last 2 weeks or 5 half-lives.I am on blood thinners or have a bleeding disorder.My kidney function, measured by creatinine or its clearance, is within the required range.I have had allergic reactions or stomach issues from pain relievers like ibuprofen.I have taken more than 4 doses of NSAIDs or COX-2 inhibitors in the last 2 weeks.My heart condition limits my physical activity.I have had diverticulitis or a GI bleed in the last 2 years.I have not received any live vaccines in the last 30 days.I have active or untreated brain metastases.
- Group 1: TPST-1495 in combination with pembrolizumab dose expansion
- Group 2: TPST-1495 monotherapy dose escalation
- Group 3: TPST-1495 monotherapy dose and schedule optimization
- Group 4: TPST-1495 monotherapy dose expansion
- Group 5: TPST-1495 in combination with pembrolizumab dose and schedule optimization
- 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
To what extent is Pembrolizumab employed therapeutically?
"Pembrolizumab is typically utilized to treat malignant neoplasms, but it has also been prescribed for unresectable melanoma, microsatellite instability high cases and situations where chemotherapy fails."
How many participants is the clinical trial seeking to recruit?
"The total number of participants necessary to run the trial is 175 and they must all meet the set inclusion criteria. Tempest Therapeutics will be hosting clinical trials at two sites: SCRI-OK Stephenson Cancer Center located in Oklahoma City, Oklahoma and South Texas Accelerated Research Therapeutics (START) based in San Antonio, Texas."
Has Pembrolizumab been given the go-ahead by federal authorities?
"The safety of Pembrolizumab is rated as 1 due to its position in the clinical trial process; limited data exists that supports both efficacy and safety."
Is this research currently open to participants?
"According to the most recent update on clinicaltrials.gov, this experiment is still searching for participants after being initially announced on May 6th 2020. The study was last updated 28 February 2022."
Has Pembrolizumab been studied for other purposes beyond its current clinical trial?
"The initial research into pembrolizumab began in 2010 at the City of Hope. Since then, there have been 251 concluded studies and 961 active ones, many based out of Oklahoma City."
Are there numerous medical centers conducting this clinical research in the state?
"Currently, enrolment is being accepted at 9 different sites across the United States. These locations include Oklahoma City, San Antonio and Philadelphia among other cities; thus minimising any inconvenience of travelling if you join this trial."
What are the ultimate objectives of this clinical experiment?
"The primary objective of this clinical trial, which will span up to two years from the commencement of treatment and ending at termination visit is to accurately identify the maximum tolerated dose and/or recommended Phase 2 dosage (RP2D) as well as an optimal dosing schedule for TPST-1495 when used alone or in combination with pembrolizumab. Secondary objectives include assessing pharmacokinetics such as clearances (CL), recording any adverse events via NCI-CTCAE v.5.0, along with estimating preliminary efficacy by determining a duration of response (DoR)."
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