STC-1010 for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment called STC-1010 for individuals with advanced colorectal cancer that cannot be surgically removed. The researchers will evaluate the safety and effectiveness of STC-1010 when combined with standard cancer treatments. The trial consists of two parts: the first part determines the optimal dose, and the second part assesses its effects on a larger group. Participants should have a specific type of unresectable colon or rectum cancer and must not have received treatment for metastatic disease. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies found STC-1010 to be safe in mice, allowing researchers to begin this first trial in humans. This treatment represents a new kind of immunotherapy, using the body's immune system to fight cancer. As the trial is in its early stages, researchers are still learning about its effects on people.
Since this is the first human test of STC-1010, detailed safety information is not yet available. However, researchers are focusing on safety and how well participants tolerate the treatment. This careful approach ensures that any side effects are closely monitored.
If these early tests confirm the treatment's safety, it will progress to larger trials. This step-by-step process is designed to protect participants and ensure their safety.12345Why are researchers excited about this study treatment for colorectal cancer?
Researchers are excited about STC-1010 for colorectal cancer because it offers a novel approach to treatment by specifically targeting tumors with certain genetic profiles. Unlike traditional chemotherapy which attacks all rapidly dividing cells, STC-1010 is designed to be effective against BRAF wild type and KRAS mutated tumors, which are common in advanced colorectal cancer. This targeted action may result in fewer side effects and potentially better outcomes for patients with these genetic markers. Additionally, by focusing on microsatellite instability-high (MSI-H) and microsatellite stable (MSS) disease types, STC-1010 could provide a more personalized treatment option, addressing the specific needs of different patient groups.
What evidence suggests that this trial's treatments could be effective for colorectal cancer?
Research has shown that STC-1010, a new cancer vaccine, has promising results in early studies. These studies, conducted on mice and in lab tests, demonstrated a significant decrease in tumor size, indicating that STC-1010 might effectively shrink tumors. Additionally, the vaccine was well-tolerated in these tests, suggesting it could be safe for humans. This trial will evaluate STC-1010 in different participant groups, including those with microsatellite instability-high (MSI-H) and microsatellite stable (MSS) colorectal cancer. Although limited human data exists, these early results provide a strong basis for believing it could help treat colorectal cancer.12367
Are You a Good Fit for This Trial?
This trial is for adults with advanced colorectal cancer that can't be surgically removed. They should have a life expectancy over 3 months, agree to use contraception, and have had certain prior treatments more than 6 months ago. A biopsy is required if safe and possible. Participants must be fairly active (ECOG ≤1), or very active if over 70 years old.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I: Dose Escalation
Dose escalation to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of STC-1010 + IS regimen with SOC therapy
Phase IIA: Expansion
Expansion stage to evaluate clinical efficacy and safety of STC-1010 at the identified RP2D
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- STC-1010
Trial Overview
The study tests STC-1010 combined with an immunostimulant regimen and standard chemotherapy in two phases: first to find the safest dose, then to assess its effectiveness on a larger group of patients across Europe and the US.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Evaluation of safety and efficacy in BRAF wild type, KRAS mutated, unresectable stage IIIC (T4b) or unresectable stage IV CRC participants with microsatellite instability-high (MSI-H) disease
Evaluation of safety and efficacy in BRAF wild type, KRAS mutated, unresectable stage IIIC (T4b) or unresectable stage IV CRC participants with MSS disease
Dose-escalation and small expansion study in BRAF wild type, KRAS mutated, unresectable stage IIIC (T4b) or unresectable stage IV CRC participants with microsatellite stable (MSS) disease who have not received prior treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brenus Pharma
Lead Sponsor
Citations
1.
aacrjournals.org
aacrjournals.org/cancerres/article/84/6_Supplement/5003/737023/Abstract-5003-Efficacy-of-the-STC-1010-a-newEfficacy of the STC-1010 a new allogenic cancer vaccine in ...
The good tolerability and reproducible efficiency of the STC-1010 vaccine in these different clinical models allow to plan a first-in-human ...
BreAK CRC, a first-in-human phase I/II trial of STC-1010 ...
BREAK-CRC is meant to clinically confirm the promising preclinical outcomes obtained on different syngeneic mouse models and ex-vivo assays ...
Study Details | NCT06934538 | First-in-human Trial of STC ...
This is a phase I/IIA, first-in-human (FIH), two-part, open-label, multicenter study to characterize the safety, tolerability profile, and clinical efficacy ...
1179 Efficacy study of STC-1010 antitumor vaccine ...
Results At Day16, all groups treated by 6CL-SH had a significant reduction of the mean tumor volume compared to the control group (p=0,0011), as ...
BreAK CRC, a first-in-human phase I/II trial of STC-1010, ...
BREAK-CRC is meant to clinically confirm the promising preclinical outcomes obtained on different syngeneic mouse models and ex-vivo assays about the potential ...
6.
ctv.veeva.com
ctv.veeva.com/study/first-in-human-trial-of-stc-1010-an-immunotherapy-in-patients-with-unresectable-locally-advanced-oFirst-in-human Trial of STC-1010, an Immunotherapy, in ...
This is a phase I/IIA, first-in-human (FIH), two-part, open-label, multicenter study to characterize the safety, tolerability profile, and clinical efficacy of ...
Ht-29-A – Application in Therapy and Current Clinical ...
This article discusses the clinical trials of STC-1010, an innovative immunotherapy drug being tested for patients with advanced or metastatic colorectal cancer ...
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