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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG PS score ≤ 1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective.
Who is the study for?
This trial is for adults with advanced solid tumors who have a life expectancy of at least 12 weeks, can consent to the study, and agree to use contraception. They must have at least one measurable tumor and be in good physical condition (ECOG PS ≤1). People with active brain metastases, recent cancer treatments or major surgeries, certain infections like hepatitis or COVID-19, autoimmune diseases needing treatment within 2 years, severe allergies to checkpoint inhibitors, or serious heart conditions cannot join.Check my eligibility
What is being tested?
The trial is testing hSTC810 as a solo therapy for people with advanced solid tumors. It aims to evaluate how safe it is and how the body processes it (pharmacokinetics), along with an initial look at its effectiveness against the tumors.See study design
What are the potential side effects?
While specific side effects of hSTC810 are not listed here, common side effects from similar therapies may include fatigue, nausea, skin reactions at injection sites, immune-related issues such as inflammation in organs like lungs or intestines; however individual experiences may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all my pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of AEs, SAEs, and abnormalities in Lab
Incidence of DLTs
Secondary outcome measures
Area under the plasma concentration - time curve (AUC0-t)
Best overall response (BOR)
Clinical Benefit rate (CBR)
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: hSTC810Experimental Treatment1 Intervention
6 escalating doses of hSTC810 will be administered to participants
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hSTC810
2022
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
STCube, Inc.Lead Sponsor
1 Previous Clinical Trials
130 Total Patients Enrolled
Medical directorStudy DirectorSTCube, Inc.
1 Previous Clinical Trials
3,032 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need high doses of steroids or other drugs that weaken my immune system.You have had a transplant using someone else's stem cells or organs in the past.I haven't had any cancer treatment in the last 4 weeks.Any side effects from my previous treatments have mostly gone away.I am currently being treated for an infection with medication.I have active tuberculosis.My cancer has spread to my brain.I haven't had a stroke, severe heart issues, or heart attack in the last 6 months.I have had another type of cancer within the last 3 years.I have not received a live vaccine in the last 30 days.I have an autoimmune disease treated with medication in the last 2 years.I have a known history of HIV.I have a history of lung scarring or inflammation not caused by infections.I have not had radiotherapy or major surgery in the last 4 weeks.Your doctor believes that you will likely live for at least 12 more weeks.You have another medical condition in addition to the one being studied.I am 18 years old or older.You have had a severe allergic reaction (Grade 3 or higher) to any checkpoint inhibitor medication.I am willing and able to sign the consent form.I am fully active and can carry on all my pre-disease activities without restriction.
Research Study Groups:
This trial has the following groups:- Group 1: hSTC810
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 benefits that researchers expect to see from this clinical trial?
"The primary outcome that will be observed and compared over a period of 90 days is the incidence of DLTs. Other outcomes of interest include time to maximum plasma concentration (Tmax), objective response rate (ORR), and minimum plasma concentration (Cmin)."
Answered by AI
Could you give me a guesstimate as to how many people are enrolled in this experiment?
"To move forward, this clinical trial requires 66 participants that meet the specific inclusion criteria. Presently, patients that are interested can sign up at MD Anderson Cancer Center in Houston, Texas or Mount Sinai Hospital in New york, New York."
Answered by AI
What is the hSTC810 FDA status?
"Given that this is a Phase 1 trial, hSTC810 has not been extensively tested yet and received a 1 for safety."
Answered by AI
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