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Ht-29-B

This article discusses the clinical trials of STC-1010, an innovative immunotherapy drug being tested for patients with advanced or metastatic colorectal cancer. The BreAK CRC trial aims to evaluate the safety, efficacy, and optimal dosing of STC-1010 when combined with standard-of-care treatments. This study offers hope for patients with limited treatment options and may potentially improve outcomes for those battling this challenging disease.

Table of Contents

What is STC-1010?

STC-1010 is a new immunotherapy drug being studied for the treatment of advanced or metastatic colorectal cancer. It is currently undergoing clinical trials to assess its safety and effectiveness[1]. STC-1010 is also known as “Stimulated Tumor Cells-1010,” which gives us a clue about how it works.

How Does STC-1010 Work?

STC-1010 is a type of cell therapy, which means it uses specially prepared cells to fight cancer. It contains six different components, each derived from different colorectal cancer cell lines:

  • HCT116-A and HCT116-B
  • HT-29-A and HT-29-B
  • LOVO-A and LOVO-B
These cells are likely modified to stimulate the patient’s immune system to recognize and attack cancer cells more effectively[1].

STC-1010 is administered as a solution for injection, typically given intradermally (into the skin)[1]. This method of administration helps to activate the immune system locally.

Who Might Benefit from STC-1010?

STC-1010 is being studied in patients with:

  • Unresectable locally advanced colorectal cancer (cancer that has spread locally but cannot be surgically removed)
  • Metastatic colorectal cancer (cancer that has spread to other parts of the body)
The trial is focusing on two main groups of patients[1]:
  1. Patients with MSS (microsatellite stable) tumors who haven’t received prior treatment
  2. Patients with MSI-H (microsatellite instability-high) tumors, including those with Lynch syndrome, who have progressed after at least 4 months of prior immunotherapy

Clinical Trial Details

The clinical trial for STC-1010 is called the “BreAK CRC trial” and is divided into two phases[1]:

Phase I: Dose Escalation

This phase aims to:

  • Determine the safety of STC-1010 when combined with standard chemotherapy
  • Find the right dose for further testing
Patients in this phase will receive STC-1010 along with a chemotherapy regimen called mFOLFOX6 and a drug called bevacizumab[1].

Phase IIA: Cohort Expansion

This phase will further test STC-1010 in two groups:

  • Arm 2A-1: Patients with MSS tumors receiving first-line treatment
  • Arm 2A-2: Patients with MSI-H tumors who have progressed after prior immunotherapy
The main goal is to see how well STC-1010 works in stopping cancer growth or shrinking tumors[1].

Eligibility Criteria

To participate in the trial, patients must meet certain criteria. Some key points include[1]:

Inclusion Criteria:

  • Age 18-75 years
  • Confirmed diagnosis of unresectable locally advanced or metastatic colorectal cancer
  • Adequate organ function (blood counts, liver, and kidney function)
  • Measurable disease according to specific criteria (RECIST 1.1)

Exclusion Criteria:

  • Rapidly progressing disease with life-threatening complications
  • Active autoimmune diseases
  • Recent major surgery or radiation therapy
  • Active infections or other severe medical conditions

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks to consider:

Potential Benefits:

  • Access to a new treatment that may be more effective than standard therapies
  • Close monitoring and care from a specialized medical team
  • Contribution to the advancement of cancer research

Potential Risks:

  • Unknown side effects or unexpected reactions to the treatment
  • The treatment may not be effective for everyone
  • Time commitment for frequent hospital visits and tests

It’s important to discuss these potential benefits and risks thoroughly with your healthcare provider before considering participation in the clinical trial[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 Phase I: Safety profile and optimal dose determination
Phase IIA: Clinical efficacy assessment
Key Eligibility Adults 18-75 years, specific tumor characteristics (MSS or MSI-H), adequate organ function
Treatment Regimen STC-1010 + standard of care (mFOLFOX6 + bevacizumab)
Primary Endpoint Phase IIA: Progression-free survival rate at 12 months

FAQ

  • What is STC-1010 and how does it work? STC-1010 is an immunotherapy drug being tested for advanced colorectal cancer. It works by stimulating the body's immune system to fight cancer cells. The drug is administered along with standard chemotherapy and other treatments to potentially enhance their effectiveness.
  • 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 main objectives of the trial? The trial has two phases. Phase I aims to assess the safety of STC-1010 and determine the optimal dose. Phase IIA focuses on evaluating the clinical efficacy of STC-1010 when combined with standard treatments for colorectal cancer.
  • What treatments will participants receive during the trial? Participants will receive STC-1010 along with standard-of-care treatments. This includes chemotherapy regimens like mFOLFOX6 and targeted therapy with bevacizumab. The exact treatment plan may vary depending on which arm of the study a participant is assigned to and their disease characteristics.
  • How long will participants be followed in the trial? The trial will monitor participants for at least 12 months to assess progression-free survival. However, the total duration of follow-up may be longer to gather comprehensive data on the long-term effects and efficacy of the treatment.

Ongoing Clinical Trials on Ht-29-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 your immune system fight cancer cells.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Unresectable: A tumor that cannot be completely removed by surgery.
  • Standard of Care (SOC): The best known treatment currently used for a specific condition.
  • mFOLFOX6: A chemotherapy regimen used to treat colorectal cancer, consisting of multiple drugs given in a specific order.
  • Bevacizumab: A targeted therapy drug that works by blocking the growth of new blood vessels that feed tumors.
  • Microsatellite Stable (MSS): A characteristic of some colorectal cancers where the DNA repair mechanism is functioning normally.
  • Microsatellite Instability-High (MSI-H): A characteristic of some colorectal cancers where there are many changes in certain areas of DNA.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors – a set of rules used to measure if tumors are responding to treatment.
  • Dose-Limiting Toxicity: Side effects of a treatment that are severe enough to prevent increasing the dose.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.

References

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