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Pembrolizumab + SO-C101 for Advanced/Metastatic Solid Tumors
Study Summary
This trial is testing a new drug, SO-C101, for safety and effectiveness in treating solid tumors. The trial will test the drug alone and in combination with another drug, pembrolizumab.
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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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- You have cancer that has spread to your brain or spinal cord and have not received any treatment for it.You are allergic to any of the ingredients in the pembrolizumab drug (KeytrudaTM).You have had a solid organ or stem cell transplant in the past.You have another cancer that is getting worse and needs treatment.You have taken medications that are similar to IL-2 or IL-15 in the past, such as rhIL-15, ALT-803, or NKTR-214.Your white blood cell count is less than 2.0 ×109/L.You have a history of lung disease or chronic inflammatory conditions.Your absolute lymphocyte count is less than 0.5 billion per liter.Your white blood cell count is too low.Your platelet count is less than 100 billion per liter.You have an ongoing autoimmune disease, poorly controlled asthma, or a history of certain syndromes that needed strong medication. Exceptions are made for vitiligo and resolved childhood asthma/allergies.You have advanced cancer that has not responded well to current treatments or that you cannot tolerate.You are expected to live for at least 3 more months.You must have a measurable tumor that has either not been treated with radiation before or has shown growth since being treated with radiation.You have recovered from any side effects of previous treatment, except for mild hair loss or stable mild nerve pain.You have tumor tissue that can be easily obtained for a fresh biopsy.You should be in good physical condition, with an ECOG performance score of 0-1. If your score is 2, you'll need to talk to the study doctor to see if you can still join the trial.
- Group 1: Part D1 (SO-C101 divided dosing, Monotherapy, dose expansion at RP2D identified in Part A1)
- Group 2: Experimental: Part A (SO-C101 Monotherapy)
- Group 3: Experimental: Part B (SO-C101 combined with pembrolizumab)
- Group 4: Experimental: Part A1 (SO-C101 divided dosing, Monotherapy)
- Group 5: Experimental: Part B1 (SO-C101 divided dosing, combined with pembrolizumab)
- Group 6: Experimental: Part D (SO-C101 Monotherapy, dose expansion at the RP2D identified in Part A)
- 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 are the desired results from this experiment?
"The primary objective of the trial, which spans 12 months from screening to completion, is to assess how many participants experience laboratory test abnormalities in urinalysis. Secondary endpoints include measuring best overall response (BOR) of SO-C101 combined with pemrolizumab by iRECIST, clinical benefit rate (CBR), and progression-free survival (PFS)."
To what extent can SO-C101 pose a risk to people's health?
"Due to the Phase 1 nature of this medication, SO-C101's safety score is a conservative 1. This accounts for the limited amount of data available concerning its efficacy and safety."
Are there still vacancies for those wishing to participate in this clinical investigation?
"Data made available on clinicaltrials.gov suggests that this medical trial is still accepting participants. It was first posted in June of 2019, and the most recent update dates back to April 8th 2022."
How many volunteers are being recruited for this clinical trial?
"Correct. Evidence available on clinicaltrials.gov displays that this medical trial, which was first listed on June 13th 2019 is actively enrolling patients. There are 200 openings at 2 different sites for prospective participants to fill."
Could you provide a comprehensive overview of the exploratory research conducted on SO-C101?
"In 2010, SO-C101 was first trialed at City of Hope. After 250 completed trials since then, 961 active clinical trials involving this medication are currently recruiting patients throughout Houston and other areas in Texas."
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