Your session is about to expire
← Back to Search
SRF388 + Pembrolizumab for Cancer
Study Summary
This trial is testing a new drug that targets a protein involved in inflammation. The drug will be given to patients with cancer to see if it is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I've had more than 4 treatments for my cancer that can't be removed by surgery, but I didn't stop PD-(L)1 inhibitors due to severe side effects.I have been treated with anti-IL-27 therapy before.My lung cancer is at an advanced stage and has been confirmed by tests.My liver cancer is moderately severe, but my liver is still functioning well.I have not had major surgery in the last 4 weeks.You must have at least one tumor that can be measured using specific guidelines.My liver cancer has a measurable tumor according to specific criteria.I had a stem cell transplant using my own cells less than 3 months ago.I can't have certain scans for my liver cancer due to an allergy or other issue.My advanced cancer has worsened despite treatment, and no other treatments are suitable for me.You must have at least 100,000 platelets per microliter of blood.I have not received anti-IL 27 therapy, except SRF388 in early trial phases.I had surgery with general anesthesia over 2 weeks ago.I have a measurable tumor in my kidney, liver, or lung cancer.My kidney cancer worsened after treatment with specific drugs.I have advanced kidney or liver cancer treated before, or my lung cancer can't be removed by surgery.My cancer has worsened despite treatment with SRF388.My NSCLC has worsened despite recent treatment.I agree to use birth control during and after the study as required.I haven't had drug treatments for cancer that can't be surgically removed or has spread.I haven't taken any cancer drugs between my SRF388 doses.My blood clotting tests are within normal limits, or if I'm on blood thinners, they're in the therapeutic range.My liver cancer worsened during or after my last treatment, which included a VEGF-targeted therapy.My blood counts meet the required levels for treatment.My liver cancer is moderately advanced, but my liver is still functioning well.I've had 3 or fewer treatments for my cancer that can't be removed by surgery, including chemotherapy and immunotherapy.Your bilirubin levels in the blood are within a certain range, except if you have a condition called Gilbert's syndrome or liver cancer with spread to the liver.My kidney cancer is not the most common type.I am fully active or can carry out light work.I have not had severe side effects from SRF388 treatment.My liver cancer is not purely hepatocellular.My kidney function, measured by creatinine or GFR, is within the required range.My liver cancer cannot be surgically removed and is at an advanced stage.Your hemoglobin levels need to be at least 9.0 g/dL for RCC or 8.5 g/dL for HCC.I am 18 years old or older.My tumor can be biopsied before and during treatment, and I agree to these procedures.I am fully active or can carry out light work.My kidney function, measured by creatinine clearance, is within the required range.I have had a severe allergic reaction to monoclonal antibody therapy or its ingredients.I have received an organ or tissue transplant from another person.Your bilirubin levels in your blood need to be within a certain range.My liver cancer is either fibrolamellar or mixed hepatocellular-cholangiocarcinoma type.I have liver cancer with at least one measurable tumor.My liver function tests are within the required range.Over half of my liver is affected by cancer.Your AST and ALT levels in your blood are not too high.I had a bone marrow transplant less than 6 months ago or have graft-versus-host disease.I have liver cancer with noticeable swelling in my abdomen.Your ANC (absolute neutrophil count) is at least 1500 per microliter.
- Group 1: Part B CHS-388 Monotherapy Expansion
- Group 2: Part C CHS-388 in Combination with Pembrolizumab
- Group 3: Part D CHS-388 in Combination with Toripalimab
- Group 4: Part A Monotherapy Dose Escalation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many participants are being monitored for this clinical research?
"To properly carry out this medical trial, 220 participants with the correct inclusion criteria must be enrolled. Those who wish to participate can do so at Vanderbilt University Medical Center in Nashville and the University of Texas Southwestern Medical Centre in Dallas."
What indications has SRF388 been employed to address?
"SRF388 is generally prescribed to treat cancerous tumors. Additionally, it can be used for conditions such as unresectable melanoma, microsatellite instability high, and chemotherapy resistance."
What potential hazards may be associated with SRF388 for individuals?
"The safety of SRF388 is estimated to be a 1 as this Phase 1 study has only minimal data backing its efficacy and security."
Has the efficacy of SRF388 been evaluated in any other scientific trials?
"Presently, 961 trials are underway for SRF388. Of those studies, 122 have reached Phase 3 testing. Houston is the epicentre of research into this treatment with 35731 sites performing clinical tests related to it."
Are there any vacancies available to participate in the experiment?
"Yes, the information on clinicaltrials.gov verifies that this trial is still recruiting participants and has been since April of 2020. Last edited in August 2022, it seeks to enroll 220 individuals at 17 different sites."
What are the intended outcomes of this experiment?
"This clinical trial's primary endpoint is to assess the safety and tolerability of SRF388 + pembrolizumab by summarizing treatment-emergent adverse events (TEAEs) during the first 28 days of treatment. Secondary endpoints include establishing a similar Safety Analysis for SRF388 alone, as well as examining Pharmacokinetics of both medications over time."
At how many sites is the trial being conducted?
"The research team at VUMC, UT Southwestern Medical Centre, City of Hope and 17 other medical centres are all conducting this clinical trial."
Share this study with friends
Copy Link
Messenger