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Monoclonal Antibodies
Pembrolizumab + SO-C101 for Advanced/Metastatic Solid Tumors
Phase 1
Waitlist Available
Led By Stephane Champiat, Dr.
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 end of treatment with nanrilkefusp alfa
Awards & highlights
No Placebo-Only Group
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.
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.
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 ~ cycle 1 day 1, 1 hour (+/-15 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1, 1 hour (+/-15 minutes)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A1: Number of participants who died
Part A1: Number of participants with AEs
Part A1: Number of participants with AEs leading to premature discontinuation of nanrilkefusp alfa
+26 moreSecondary study objectives
Part A1: CBR
Part A1: DoR
Part A1: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 1 hour (+/-15 minutes)
+50 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Part D1 (nanrilkefusp alfa divided dosing, monotherapy, expansion at the RP2D identified in Part A1)Experimental Treatment1 Intervention
Drug: Nanrilkefusp alfa, 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, relapsed/refractory advanced/metastatic melanoma
Group II: Experimental: Part D (nanrilkefusp alfa monotherapy, expansion at the RP2D identified in Part A)Experimental Treatment1 Intervention
Drug: Nanrilkefusp alfa Indications: Relapsed/refractory advanced/metastatic renal cell carcinoma, relapsed/refractory advanced/metastatic skin squamous-cell carcinoma, relapsed/refractory advanced/metastatic melanoma
Group III: Experimental: Part B1 (nanrilkefusp alfa divided dosing, combined with pembrolizumab)Experimental Treatment2 Interventions
Drug: Nanrilkefusp alfa, twice a day as 2 divided doses (50%:50%) Drug: Pembrolizumab
Group IV: Experimental: Part B (nanrilkefusp alfa combined with pembrolizumab)Experimental Treatment2 Interventions
Drug: Nanrilkefusp alfa Drug: Pembrolizumab
Group V: Experimental: Part A1 (nanrilkefusp alfa divided dosing, monotherapy)Experimental Treatment1 Intervention
Drug: Nanrilkefusp alfa, twice a day as 2 divided doses (50%:50%)
Group VI: Experimental: Part A (nanrilkefusp alfa monotherapy)Experimental Treatment1 Intervention
Drug: Nanrilkefusp alfa
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
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
2 Previous Clinical Trials
270 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: Experimental: Part A (nanrilkefusp alfa monotherapy)
- Group 2: Experimental: Part B (nanrilkefusp alfa combined with pembrolizumab)
- Group 3: Experimental: Part A1 (nanrilkefusp alfa divided dosing, monotherapy)
- Group 4: Experimental: Part B1 (nanrilkefusp alfa divided dosing, combined with pembrolizumab)
- Group 5: Experimental: Part D (nanrilkefusp alfa monotherapy, expansion at the RP2D identified in Part A)
- Group 6: Part D1 (nanrilkefusp alfa divided dosing, monotherapy, expansion at the RP2D identified in Part A1)
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.
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