Your session is about to expire
← Back to Search
Monoclonal Antibodies
SNX281 + Pembrolizumab for Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by Stingthera, Inc.
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 up to 40 months
Awards & highlights
Study Summary
This trial is testing a drug called SNX281 to see if it is safe and effective when given alone or with another drug, pembrolizumab, to people with advanced solid tumors or lymphoma. The main goals are to learn more about the drug's side effects and how well it works.
Who is the study for?
This trial is for adults with advanced solid tumors or lymphoma who've tried and didn't respond to standard treatments, including anti-PD-1/L1 antibodies. They should be relatively healthy (ECOG score of 0 or 1), not pregnant, willing to use contraception, and have a life expectancy of at least 12 weeks. People can't join if they have certain health conditions like active autoimmune diseases, serious infections, heart problems, or recent history of significant medical procedures.Check my eligibility
What is being tested?
The study tests SNX281 alone and combined with pembrolizumab in patients whose cancer hasn't responded to previous therapies. It aims to determine the safest dose levels, understand side effects and pharmacological properties of SNX281, and assess its effectiveness both as a standalone treatment and alongside pembrolizumab.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs; issues from infusion; increased risk of infections due to weakened immunity; liver problems; bleeding disorders; fatigue; allergic reactions specific to pembrolizumab's ingredients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 40 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 40 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicities to determine the maximum tolerated dose (MTD) and Recommended Phase 2 dose of SNX281
Percentage of participants who experience adverse events and serious adverse events to determine safety and tolerability of SNX281 given as a single agent and in combination with pembrolizumab (KEYTRUDA®)
Secondary outcome measures
Disease control rate (DCR) to assess the clinical activity of SNX281 given as a single agent and in combination with pembrolizumab (KEYTRUDA®)
Duration of response (DoR) to assess the clinical activity of SNX281 given as a single agent and in combination with pembrolizumab (KEYTRUDA®)
Objective response rate (ORR) to assess the clinical activity of SNX281 given as a single agent and in combination with pembrolizumab (KEYTRUDA®)
+4 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: SNX281 in Combination with pembrolizumab (KEYTRUDA®)Experimental Treatment2 Interventions
SNX281 will be administered in 3 of the 4 weeks in Cycle 1 and then once every 3 weeks of each cycle thereafter. Participants will also receive pembrolizumab (KEYTRUDA®) once every cycle for up to 6 cycles. The combination of SNX281 and pembrolizumab (KEYTRUDA®) will be given for up to 6 cycles, or until disease progression or unacceptable toxicity occurs. Participants who are, in the opinion of the investigators, benefitting from treatment may be allowed to continue treatment with SNX281 and pembrolizumab (KEYTRUDA®) (or SNX281 alone) beyond Cycle 6 with Sponsor approval. It is expected that up to approximately 68 participants will take part in this arm of the study.
Group II: SNX281 MonotherapyExperimental Treatment1 Intervention
SNX281 will be administered weekly in Cycle 1 and then once every 3 weeks of each cycle thereafter for up to 6 cycles, or until disease progression or unacceptable toxicity occurs. Participants who are, in the opinion of the investigators, benefitting from treatment may be allowed to continue treatment with SNX281 beyond Cycle 6 with Sponsor approval. It is expected that up to approximately 66 participants will take part in this arm of the study.
Subjects enrolled in the dose expansion phase of this arm may be eligible to add pembrolizumab (KEYTRUDA®) to their SNX281 therapy following identification of the maximum tolerated dose (MTD) or optimal dose of SNX281 in combination with pembrolizumab (KEYTRUDA®). Subjects must, in the opinion of the Investigator, have demonstrated tolerance to SNX281 and have experienced sub-optimal response to therapy (i.e., disease stability for 4 cycles or progression on treatment with SNX281 at any time).
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?
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,630 Total Patients Enrolled
91 Trials studying Lymphoma
8,738 Patients Enrolled for Lymphoma
Stingthera, Inc.Lead Sponsor
Melissa Johnson, MDStudy ChairSCRI Development Innovations, LLC
6 Previous Clinical Trials
855 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to meet extra requirements to safely and effectively use pembrolizumab and SNX281.Your condition has worsened after receiving PD-1/L1 treatment, as confirmed by two separate assessments at least four weeks apart.You have shown signs of disease progression within 12 weeks after receiving treatment with anti-PD-1/L1 mAb.You have another type of cancer that may affect your safety or ability to participate in the study.You have cancer that has spread to your brain and are having symptoms from it, or your cancer in the brain is not stable.You have a medical condition that requires medication to weaken your immune system.You have a history of blood vessel inflammation.You've received a live vaccine in the 30 days before starting treatment.You have had a bone marrow or solid organ transplant in the past.You have advanced or recurring cancer or lymphoma that has not responded to standard treatments or you are unable to receive standard treatments.You or your legal guardian have signed a paper saying that you agree to participate in the study before any tests are done.You must be 18 years or older to participate and sign the informed consent form.You are able to carry out your normal daily activities without restrictions or with only slight restrictions due to your medical condition.You have undergone treatment to reduce your allergic reactions in the recent past.You have a history or signs of heart problems.You have recently experienced symptoms of pericarditis, which is inflammation of the lining around the heart.You have fluid buildup in your abdomen or around your lungs that is causing noticeable symptoms.You have a serious and unstable medical or mental condition that may affect your safety, ability to understand the study, or follow instructions.You have been treated with certain medications before.You had radiation therapy recently and have not yet fully recovered from it.You are currently using drugs or alcohol excessively.You have already been treated with at least two doses of an approved anti-PD-1/L1 medication.You have been diagnosed with advanced or recurrent cancer that has not responded to previous treatment with checkpoint inhibitors.You have a tumor that can be measured or evaluated using specific criteria. If you are in the later stages of the study, you must have at least one tumor that can be measured and has not been treated with radiation before or has grown after being treated with radiation.You have advanced or recurrent ovarian or colorectal cancer and have not responded well to standard treatments or are unable to receive them. You may not have received checkpoint inhibitor therapy before. If you are eligible to receive pembrolizumab, you must meet additional medical requirements.You recently had a severe infection in your intestines, inflammation in your bowels, or blockage in your digestive system.
Research Study Groups:
This trial has the following groups:- Group 1: SNX281 Monotherapy
- Group 2: SNX281 in Combination with pembrolizumab (KEYTRUDA®)
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 conditions is SNX281 typically administered for?
"SNX281 is primarily used for the treatment of malignant neoplasms, but can also be beneficial in managing cases of unresectable melanoma, high microsatellite instability, and disease progression after chemotherapy."
Answered by AI
Are there any adverse effects associated with SNX281 that patients should be aware of?
"In light of the Phase 1 nature of this trial, SNX281's safety is provisionally rated as a one due to its nascent data with regards to efficacy and risk."
Answered by AI
Are there numerous facilities conducting this analysis in North America?
"This medical study is being conducted in several centres, including Thomas Jefferson University Sidney Kimmel Cancer Center in Philadelphia, Pennsylvania; Tennessee Oncology located in Nashville; and Sarah Cannon Research Institute at HealthONE situated within Denver, Colorado."
Answered by AI
Has SNX281 been investigated in any other research?
"Currently, SNX281 is being tested in 961 live trials with 122 of those studies having reached Phase 3. Houston, Texas serves as the epicentre for research on this drug; however 35731 other locations are running related studies."
Answered by AI
Are there any vacancies open for prospective participants in this experiment?
"Affirmative. According to the information on clinicaltrials.gov, this medical exploration is actively recruiting patients and was initially posted on November 18th 2020. It requires 134 participants from 4 different locations for its completion."
Answered by AI
How many participants are actively enrolled in this clinical experiment?
"Merck Sharp & Dohme LLC, the sponsor of this medical trial, is in need of 134 patients who meet the criteria outlined. The study will take place at Thomas Jefferson University, Sidney Kimmel Cancer Center (Philadelphia) and Tennessee Oncology (Nashville)."
Answered by AI
What are the chief aims of this investigation?
"This clinical trial is intended to measure the maximum tolerated dose (MTD) and recommended phase II dosing of SNX281. The primary outcome assessed over a 20-week period will be incidence of dose limiting toxicities, while secondary objectives include progression free survival (PFS), objective response rate (ORR), and plasma concentration measurements in order to characterize pharmacokinetic parameters associated with this medication taken either as single agent or combination therapy."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger