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Monoclonal Antibodies
Pembrolizumab + SO-C101 for Advanced/Metastatic Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by Sotio a.s.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, through study completion, an average of 1 year
Awards & highlights
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.
Who is the study for?
Adults with certain advanced or metastatic solid tumors, who haven't responded to standard treatments, can join this trial. They must have a life expectancy of at least 3 months, one measurable tumor lesion, and be in good enough health as per specific criteria. Pregnant women and those with untreated brain metastases or severe allergies to pembrolizumab's ingredients cannot participate.Check my eligibility
What is being tested?
The study is testing SO-C101 alone and combined with pembrolizumab (Keytruda) for safety and early signs of effectiveness against various advanced cancers. It's an open-label phase 1/1b trial where all participants know what treatment they're getting.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to pembrolizumab, such as inflammation in organs like the lungs or colon, skin rashes, hormone gland problems (like thyroid), fatigue, infusion reactions from the drugs being administered intravenously.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening, through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Electrocorticogram
Part A;Number of Participants With Adverse Events (AEs) According to Severity of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0
Part A;Number of Participants With Clinically Significant Change From Screening in Vital Signs
+13 moreSecondary outcome measures
Immunogenicity analysis to assess antibodies to SO-C101
Part A Best overall response (BOR)
Part A Clinical benefit rate (CBR)
+11 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Part D1 (SO-C101 divided dosing, Monotherapy, dose expansion at RP2D identified in Part A1)Experimental Treatment1 Intervention
Drug: SO-C101, twice a day as 2 divided doses (50%:50%) Indications: Relapsed/refractory advanced/metastatic renal cell carcinoma, relapsed/refractory advanced/metastatic skin squamous-cell carcinoma, and relapsed/refractory advanced/metastatic melanoma.
Group II: Experimental: Part D (SO-C101 Monotherapy, dose expansion at the RP2D identified in Part A)Experimental Treatment1 Intervention
Drug: SO-C101 Indications: Relapsed/refractory advanced/metastatic renal cell carcinoma, relapsed/refractory advanced/metastatic skin squamous-cell carcinoma, and relapsed/refractory advanced/metastatic melanoma.
Group III: Experimental: Part B1 (SO-C101 divided dosing, combined with pembrolizumab)Experimental Treatment2 Interventions
Drug: SO-C101, twice a day as 2 divided doses (50%:50%) Drug: pembrolizumab
Group IV: Experimental: Part B (SO-C101 combined with pembrolizumab)Experimental Treatment2 Interventions
Drug: SO-C101 Drug: pembrolizumab
Group V: Experimental: Part A1 (SO-C101 divided dosing, Monotherapy)Experimental Treatment1 Intervention
Drug: SO-C101, twice a day as 2 divided doses (50%:50%)
Group VI: Experimental: Part A (SO-C101 Monotherapy)Experimental Treatment1 Intervention
Drug: SO-C101
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
Find a Location
Who is running the clinical trial?
Sotio a.s.Lead Sponsor
13 Previous Clinical Trials
1,913 Total Patients Enrolled
SOTIO a.s.Industry Sponsor
15 Previous Clinical Trials
2,058 Total Patients Enrolled
SOTIO Biotech a.s.Industry Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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)."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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