#1 Clinical Trials Search in Europe

Hct116-B

This article discusses the ongoing clinical trials of STC-1010, an innovative immunotherapy drug being tested for patients with advanced or metastatic colorectal cancer. The BreAK CRC trial is a Phase I/IIA study aimed at evaluating the safety, efficacy, and optimal dosing of STC-1010 when combined with standard-of-care treatments. This research offers hope for patients with difficult-to-treat forms of colorectal cancer, particularly those who have not responded to previous therapies.

Table of Contents

What is STC-1010?

STC-1010, also known as Stimulated Tumor Cells-1010, is a new type of cancer treatment called immunotherapy[1]. It is currently being studied as a potential treatment for advanced colorectal cancer. STC-1010 is made up of specially prepared cells that come from colorectal cancer tumors[1].

How does STC-1010 work?

STC-1010 works by stimulating your body’s immune system to fight cancer cells. It contains six different types of cancer cells that have been modified in a laboratory:

  • HCT116-A and HCT116-B
  • HT-29-A and HT-29-B
  • LOVO-A and LOVO-B
These modified cancer cells are designed to activate your immune system and help it recognize and attack similar cancer cells in your body[1].

What conditions does STC-1010 treat?

STC-1010 is being studied for the treatment of unresectable locally advanced or metastatic colorectal cancer. This means:

  • Unresectable: The cancer cannot be completely removed with surgery
  • Locally advanced: The cancer has spread from where it started to nearby tissue or lymph nodes
  • Metastatic: The cancer has spread to other parts of the body
Specifically, it is being tested in patients with colorectal cancer that is either stage IIIC (T4b) or stage IV[1].

Current research on STC-1010

STC-1010 is currently being studied in a clinical trial called the BreAK CRC trial. This trial has two main parts:

  1. Phase I: This part aims to determine the safety of STC-1010 and find the right dose to use.
  2. Phase IIA: This part will test how well STC-1010 works in treating colorectal cancer.
The study is testing STC-1010 in combination with other cancer treatments, including chemotherapy (like FOLFOX) and other targeted therapies (like bevacizumab)[1].

Who may be eligible for STC-1010 treatment?

The clinical trial is looking at two main groups of patients:

  1. Patients with MSS (microsatellite stable) colorectal cancer who haven’t had treatment before.
  2. Patients with MSI-H (microsatellite instability-high) colorectal cancer, including those with Lynch syndrome, whose cancer has gotten worse after at least 4 months of immunotherapy.
To be eligible, patients must:
  • Be between 18 and 75 years old
  • Have a life expectancy of more than 3 months
  • Have cancer that can be measured
  • Have good overall health and organ function
There are also several factors that might make someone ineligible for the trial, such as having certain other medical conditions or having had specific treatments recently[1].

Potential side effects and safety considerations

As STC-1010 is still in the early stages of testing, all of its potential side effects are not yet known. The clinical trial is designed to carefully monitor patients for any side effects or safety concerns. Some general considerations for patients receiving immunotherapy treatments like STC-1010 include:

  • Immune-related side effects, which can affect various parts of the body
  • Potential interactions with other medications, especially those that affect the immune system
  • The need for close monitoring by healthcare professionals throughout treatment
It’s important to note that STC-1010 is still an experimental treatment and is not yet approved for general use. Patients considering participating in the clinical trial should discuss the potential risks and benefits thoroughly with their healthcare team[1].

Aspect Details
Study Name BreAK CRC trial (BreAK for Brenus Anti-cancer)
Drug Tested STC-1010 (immunotherapy)
Target Condition Unresectable locally advanced or metastatic colorectal cancer
Study Design Open-label, multicenter, Phase I/IIA trial
Primary Objectives Safety profile, optimal dose determination, clinical efficacy
Key Eligibility Adults 18-75, specific tumor characteristics (MSS or MSI-H)
Treatment Combination STC-1010 with mFOLFOX6 + bevacizumab, followed by maintenance therapy
Primary Endpoint Progression-free survival rate at 12 months (Phase IIA)

FAQ

  • What is STC-1010 and how does it work? STC-1010 is an immunotherapy drug designed to treat advanced or metastatic colorectal cancer. It works by stimulating the body's immune system to fight cancer cells. The drug is being tested in combination with standard treatments to potentially improve outcomes for patients.
  • Who is eligible for the BreAK CRC trial? The trial is primarily for adults aged 18-75 with unresectable locally advanced or metastatic colorectal cancer. Participants must meet specific health criteria, including adequate organ function and performance status. The study includes different arms for patients with specific tumor characteristics, such as MSS (microsatellite stable) or MSI-H (microsatellite instability-high) tumors.
  • What are the phases of the BreAK CRC trial? The trial consists of two main phases. Phase I is a dose escalation study to determine the safety and optimal dose of STC-1010. Phase IIA is a cohort expansion study to further evaluate the drug's efficacy in specific patient groups, including those with MSS and MSI-H tumors.
  • What treatments are given alongside STC-1010 in the trial? STC-1010 is administered alongside standard-of-care treatments. For most participants, this includes mFOLFOX6 (a chemotherapy regimen) plus bevacizumab during the induction phase, followed by maintenance therapy with 5-fluorouracil/leucovorin or capecitabine plus bevacizumab.
  • What are the main goals of the BreAK CRC trial? The primary objectives of the trial are to assess the safety profile of STC-1010 when combined with standard treatments, determine the optimal dose, and evaluate its clinical efficacy. For Phase IIA, a key endpoint is the progression-free survival rate at 12 months from the start of treatment.

Ongoing Clinical Trials on Hct116-B

  • Study on STC-1010 and Drug Combination for Patients with Advanced or Metastatic Colorectal Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France

Glossary

  • Colorectal Cancer (CRC): A type of cancer that starts in the colon or rectum, which are parts of the large intestine.
  • Immunotherapy: A type of cancer treatment that helps the body's immune system fight cancer cells.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Unresectable: Tumors that cannot be completely removed through surgery.
  • Standard of Care (SOC): The best known treatment currently used for a specific condition or disease.
  • mFOLFOX6: A combination chemotherapy regimen used to treat colorectal cancer, consisting of oxaliplatin, leucovorin, and fluorouracil.
  • Bevacizumab: A targeted therapy drug that works by blocking the growth of new blood vessels that feed tumors.
  • Microsatellite Stable (MSS): A type of colorectal cancer where the DNA repair mechanism is functioning normally.
  • Microsatellite Instability-High (MSI-H): A type of colorectal cancer characterized by a high number of genetic mutations due to defects in DNA repair mechanisms.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Dose-Limiting Toxicity: Side effects of a treatment that are severe enough to prevent an increase in dosage or require a decrease in dosage.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Induction Treatment: The initial treatment given to reduce cancer size before the main treatment.
  • Maintenance Therapy: Treatment given to help keep cancer from coming back after it has responded to initial therapy.

References

  1. http://clinicaltrials.eu/trial/study-on-stc-1010-and-drug-combination-for-patients-with-advanced-or-metastatic-colorectal-cancer/