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Checkpoint Inhibitor
SOT101 + Pembrolizumab for Advanced Cancers
Phase 2
Waitlist Available
Research Sponsored by SOTIO Biotech AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have adequate organ function including hematological, renal, and hepatic function
Participants must have measurable disease per RECIST 1.1. mCRPC participants with no measurable disease and only widespread bone disease must have a CTC count of >5 cells per 7.5 mL of blood
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1 to cycle 3 day 1 (up to approximately 9 weeks, where each cycle is 3 weeks)
Awards & highlights
Study Summary
This trialis testing a new drug to see if it can help fight cancer.
Who is the study for?
This trial is for adults with certain advanced solid tumors, including lung, colorectal, liver, prostate and ovarian cancers. They must have a tumor that can be biopsied (except some prostate cancer cases), measurable disease or specific blood markers, good performance status (ECOG 0-1), stable side effects from past treatments except hair loss and mild neuropathy, proper organ function and no active hepatitis infections. Participants cannot join if they've had severe reactions to immune therapies before or recent major surgeries.Check my eligibility
What is being tested?
The study tests the effectiveness of SOT101 combined with Pembrolizumab in treating selected tumors. It aims to see how well this combination works against different types of advanced cancers by measuring changes in tumor size and other indicators of response.See study design
What are the potential side effects?
Potential side effects may include immune-related issues such as inflammation in various organs like the lungs or intestines; infusion reactions during treatment administration; fatigue; skin reactions; hormonal gland problems leading to hormone imbalances; and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood, kidney, and liver functions are all within normal ranges.
Select...
My cancer can be measured by scans or I have a high number of cancer cells in my blood.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 day 1 to cycle 3 day 1 (up to approximately 9 weeks, where each cycle is 3 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1 to cycle 3 day 1 (up to approximately 9 weeks, where each cycle is 3 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
Secondary outcome measures
Best Overall Response (BOR) According to RECIST 1.1
Clinical Benefit Rate (CBR) According to RECIST 1.1
Duration of Response (DoR) According to RECIST 1.1
+18 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Nanrilkefusp Alfa and PembrolizumabExperimental Treatment2 Interventions
Participants will be treated with 12 μg/kg of nanrilkefusp alfa on Day 1, Day 2, Day 8, and Day 9 of each 3-week cycle in combination with 200 mg pembrolizumab on Day 1 of each 3-week cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
SOTIO Biotech AGLead Sponsor
4 Previous Clinical Trials
402 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,233 Total Patients Enrolled
2 Trials studying Liver Cancer
133 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung inflammation that needed steroids or have it now.My blood, kidney, and liver functions are all within normal ranges.My cancer can be measured by scans or I have a high number of cancer cells in my blood.I don't have major heart issues, uncontrolled high blood pressure, or a stem cell transplant in the last 5 years.I have been treated with drugs that target IL-2 or IL-15.I haven't taken any cancer drugs or been in a drug study recently.I have not received a live vaccine in the last 30 days.I have not had major surgery or radiotherapy recently.You do not have an active hepatitis B or hepatitis C infection.I am using effective birth control.I have a confirmed diagnosis of either NSCLC, colorectal cancer, cSCC, advanced hepatocellular carcinoma, mCRPC, or ovarian cancer.I can provide a fresh biopsy of my tumor, except if I have metastatic castration-resistant prostate cancer without accessible tumor tissue.I stopped a specific cancer treatment due to severe side effects.I do not have HIV, immunodeficiency, or active brain metastases.I have been treated for an autoimmune disease in the last 2 years.You have a strong allergic reaction to pembrolizumab or any of its ingredients.I am currently being treated for an infection.I am fully active or can carry out light work.I have recovered from side effects of past treatments, except for hair loss or stable nerve pain.
Research Study Groups:
This trial has the following groups:- Group 1: Nanrilkefusp Alfa and Pembrolizumab
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.
Is participation currently open for this trial?
"Affirmative. According to the clinicaltrials.gov records, this medical experiment was first advertised on June 21st 2022 and recently revised on January 5th 2023. The investigation is looking for 320 volunteers from a single trial site."
Answered by AI
What is the current size of the participant pool in this experiment?
"Affirmative. According to the clinicaltrials.gov database, this clinical trial is actively recruiting individuals and was initially posted on June 21st 2022 before being recently amended on January 5th 2023. 320 participants are needed from a single medical facility."
Answered by AI
What risks should be taken into consideration when administering SOT101 and Pembrolizumab?
"Considering the known safety data and lack of evidence on efficacy, our research team assigned SOT101 & pembrolizumab a score of 2."
Answered by AI
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