STC-1010 for Colorectal Cancer

Recruiting at 15 trial locations

Overseen By Rebecca TANZI

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Brenus Pharma

Must be taking: mFOLFOX6, Bevacizumab

Must not be taking: Immunosuppressants

Disqualifiers: Auto-immune diseases, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 6 7}

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

I agree to have biopsies if they are safe and possible.

8. Life expectancy \> 3 months as assessed by the investigator 9. Effective contraceptive measures implemented

My cancer can be measured using specific criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

28 days

Phase IIA: Expansion

Expansion stage to evaluate clinical efficacy and safety of STC-1010 at the identified RP2D

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

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?

Group I: Phase 2A: Arm 2A-2 Experimental Treatment 1 Intervention

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

Group II: Phase 2A: Arm 2A-1 Experimental Treatment 1 Intervention

Evaluation of safety and efficacy in BRAF wild type, KRAS mutated, unresectable stage IIIC (T4b) or unresectable stage IV CRC participants with MSS disease

Group III: Phase 1 Experimental Treatment 1 Intervention

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

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-new

Efficacy 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 ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS3635

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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06934538

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 ...

4. jitc.bmj.com jitc.bmj.com/content/10/Suppl_2/A1222

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 ...

5. meetings.asco.org meetings.asco.org/abstracts-presentations/238381

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-o

First-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 ...

7. clinicaltrials.eu clinicaltrials.eu/inn/ht-29-a/

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 ...