First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer

December 19, 2025 updated by: Brenus Pharma

Open Label, Multicenter, Dose-escalation and Cohort-expansion Phase I/IIA Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer (CRC) - BreAK CRC Trial (BreAK for Brenus Anti-cancer)

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 STC-1010 associated with GM-CSF and cyclophosphamide immunostimulant (IS) regimen administered with standard of care (SOC) therapy (mFOLFOX6 with or without bevacizumab) to participants with unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) colorectal cancer (CRC).

The trial will be conducted in two parts:

  • A Phase I consisting of a dose escalation part and small expansion part to determine the maximum tolerated dose (MTD), recommended Phase II dose (RP2D) and safety profile of the STC-1010 + IS regimen administered with SOC therapy. Approximately 21 to 33 participants will be included in this phase in Europe.
  • A Phase IIA consisting of the expansion stage of the study which will further evaluate the clinical efficacy and safety of STC-1010 on a larger number of participants treated at the identified RP2D. Approximately 57 to 60 participants will be enrolled in total in 2 different arms. Multi-site recruitment will take place in Europe and in the US.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female aged 18-75 years
  2. Histologically confirmed diagnosis of unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) (R0) adenocarcinoma of the colon or rectum
  3. Adjuvant fluoropyrimidine monotherapy or oxaliplatin-based chemotherapy allowed if more than 6 months have elapsed between the end of adjuvant treatment and first relapse
  4. Determination of KRAS and BRAF mutation status
  5. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  6. Must agree to have biopsy at screening and on-treatment, only if not representing an unacceptable clinical risk and/or if technically feasible as judged by the Investigator in discussion with the interventional radiologist or endoscopist
  7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1. Participants >70 years must have a PS= 0.
  8. Life expectancy > 3 months as assessed by the investigator
  9. Effective contraceptive measures implemented

Exclusion Criteria:

  1. Patients with symptomatic ascites or pleural effusion
  2. Dihydropyrimidine dehydrogenase (DPD) deficiency
  3. Resectable tumor with curative intent or patient considered for a curative strategy by intensifying chemotherapy to induce resectability
  4. Prior chemotherapy for metastatic disease
  5. Prior immunotherapy for advanced/metastatic disease (except for Arm 2A-2)
  6. Prior therapy with an investigational agent
  7. BRAF mutation
  8. Active auto-immune diseases such as rheumatoid arthritis, lupus, Crohn's disease, ulcerative colitis
  9. Medical conditions requiring immunosuppressive therapy
  10. Major surgery <4 weeks prior to first administration of STC-1010
  11. Radiotherapy < 4 weeks prior to first administration of STC-1010 or < 2 weeks in case of palliative radiotherapy
  12. Prior stem cell or solid organ transplantation
  13. Dementia or altered mental status or subject of a legal protection measure that would prohibit informed consent
  14. Active drug or alcohol abuse as assessed by the Investigator
  15. Participant deprived of their liberty by a judicial or administrative decision, undergoing psychiatric care and admitted to a health or social establishment for purposes other than research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1
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
Biological: STC-1010 + IS regimen + SOC therapy
STC-1010 administered with immunostimulants (IS) in low-dose (cyclophosphamide and GM-CSF) and standard of care (SOC) therapy (mFOLFOX6 with or without bevacizumab)
Experimental: Phase 2A: Arm 2A-1
Evaluation of safety and efficacy in BRAF wild type, KRAS mutated, unresectable stage IIIC (T4b) or unresectable stage IV CRC participants with MSS disease
Biological: STC-1010 + IS regimen + SOC therapy
STC-1010 administered with immunostimulants (IS) in low-dose (cyclophosphamide and GM-CSF) and standard of care (SOC) therapy (mFOLFOX6 with or without bevacizumab)
Experimental: Phase 2A: Arm 2A-2
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
Biological: STC-1010 + IS regimen + SOC therapy
STC-1010 administered with immunostimulants (IS) in low-dose (cyclophosphamide and GM-CSF) and standard of care (SOC) therapy (mFOLFOX6 with or without bevacizumab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: To determine overall safety profile, recommended Phase 2 dose (RP2D) and maximum tolerated dose (MTD)
Time Frame: 28 days

Endpoint/Outcome Measures:

Incidence, severity, and relationship of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Dose-Limiting Toxicities (DLT) (in dose escalation part), AEs leading to treatment discontinuation; and clinically significant findings on clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examinations, using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
28 days
Phase 2A: To determine the clinical efficacy by Progression Free Survival (PFS) rate
Time Frame: 12 months
Progression Free Survival (PFS) rate at 12 months from STC-1010 + IS regimen initiation, defined as the proportion of participants alive and without progression (i.e., participants with complete response [CR], partial response [PR] or stable disease [SD]) at 12 months according to RECIST 1.1
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: To determine the preliminary clinical efficacy
Time Frame: 6 months
Endpoints/Outcome Measures: Overall Response Rate (ORR) at 6 months from STC-1010 + IS treatment initiation, defined as the achievement of either a complete response (CR) or partial response (PR) according to RECIST 1.1; Progression Free Survival (PFS) rate at 6 months from STC-1010 + IS treatment initiation (defined as the rate of participants alive with CR, PR or SD) according to RECIST 1.1; and Median of PFS.
6 months
Phase 2A: To determine the overall safety and tolerability profile
Time Frame: 6, 12 and 24 months
Endpoints/Outcome Measures: Incidence, severity and relationship of TEAEs, SAEs, TEAEs leading to discontinuation of study treatment; and clinically significant findings on clinical laboratory tests, vital signs, ECGs and physical examinations, using the CTCAE Version 5.
6, 12 and 24 months
Phase 2A: To determine the clinical efficacy by Clinical Benefit Rate (CBR)
Time Frame: 12 and 24 months
Clinical Benefit Rate (CBR) defined as the percentage of participants in whom the best response is CR or PR, or SD lasting for a least 6 months.
12 and 24 months
Phase 2A: To determine the clinical efficacy by Objective Response Rate (ORR)
Time Frame: 6, 12 and 24 months
Objective Response Rate (ORR) defined as the proportion of patients who achieve a complete or partial response per RECIST 1.1 criteria. Patients with unevaluable or unknown response status will be considered as non-responders.
6, 12 and 24 months
Phase 2A: To determine the clinical efficacy by Duration of Response (DOR)
Time Frame: 6,12 and 24 months
Duration of response (DOR), defined as the time from first documented evidence of CR or PR to the earliest date of documented radiological progression or death due to any cause
6,12 and 24 months
Phase 2A: To determine the clinical efficacy by Progression Free Survival (PFS)
Time Frame: 6,12 and 24 months
Progression Free Survival (PFS) defined as the time to the date of progression or death from any cause. The median PFS with it's 95% confidence interval (CI) will also be calculated
6,12 and 24 months
Phase 2A: To determine the clinical efficacy by Overall Survival (OS)
Time Frame: 12 and 24 months
Overall Survival (OS) defined as the time to the date of death from any cause. The median OS with its 95% CI will also be calculated.
12 and 24 months
Phase 2A: To determine the clinical efficacy by metastases resection rate
Time Frame: Up to 18 months
Metastases resection rate defined as the percentage of participants who undergo resection
Up to 18 months
Phase 1: To describe the effects on cell-mediated immunity
Time Frame: Up to 72 hours post injection
Assessment of delayed-type hypersensitivity (DTH) score after the first vaccination (at 1, 24, 48 and 72 hours post-STC-1010 injection) and then after the 4th, 8th and every boost
Up to 72 hours post injection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: To determine the impact on immune and molecular biomarkers (exploratory outcomes)
Time Frame: At baseline/screening (T0), 1 month, 2 months, 6 months, 12 months
Assessment of biomarkers in blood and tumor biopsies
At baseline/screening (T0), 1 month, 2 months, 6 months, 12 months
Phase 2: To determine the impact on immune and molecular biomarkers (exploratory outcomes)
Time Frame: At baseline/screening (T0), 1 month, 2 months, 6 months, 12 months and at time of progression (Tprogression, up to 24 months)
Assessment of biomarkers in blood and tumor biopsies
At baseline/screening (T0), 1 month, 2 months, 6 months, 12 months and at time of progression (Tprogression, up to 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brenus Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BreAK CRC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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