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NCT06934538 · ClinicalTrials.gov registry record · Phase 1
First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
A Phase 1 study of Unresectable Metastatic Colorectal Cancer and Unresectable Locally Advanced Colorectal Cancer, sponsored by Brenus Pharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 9
- Study locations
NCT06934538 is a Phase 1 study of Unresectable Metastatic Colorectal Cancer and Unresectable Locally Advanced Colorectal Cancer that is actively recruiting participants, run by Brenus Pharma. The registered enrollment target is 90 participants, below the 121-participant average among 3 other Unresectable Metastatic Colorectal Cancer trials with a reported enrollment target (26% lower). The trial reports 9 study locations across 2 states.
The verdict
NCT06934538, a Phase 1 study of Unresectable Metastatic Colorectal Cancer and Unresectable Locally Advanced Colorectal Cancer, is actively recruiting participants, sponsored by Brenus Pharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 9
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL STC-1010 + IS regimen + SOC therapy
Study Locations (9)
Other
- Institut Jules Bordet - Brussels
- Institut Bergonié - Bordeaux
- Centre Georges François Leclerc (CGFL) - Dijon
- Centre Léon Bérard (CLB) - Lyon
- Hospices Civils de Lyon (HCL) - Lyon
- Institut du Cancer de Montpellier (ICM) - Montpellier
- Centre Hospitalier Universitaire de Poitiers (CHU) - Poitiers
- Institut Gustave Roussy (IGR) - Villejuif
Maryland
- Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2025-06-17 |
| Est. Completion | 2029-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06934538
The ClinicalTrials.gov registry entry for NCT06934538 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 121-participant average among 3 other Unresectable Metastatic Colorectal Cancer trials with a reported enrollment target (26% lower). The listed sponsor is Brenus Pharma, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Unresectable Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which STC-1010 + IS regimen + SOC therapy is the first listed.
NCT06934538 reports 9 study locations spanning 2 distinct geographic areas - top geographies include Other, Maryland.
Frequently Asked Questions
What is clinical trial NCT06934538 about?
NCT06934538 is a clinical study titled "First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal 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...
What is the current status of trial NCT06934538?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2025-06-17. Estimated completion is 2029-06.
What conditions does trial NCT06934538 study?
This clinical trial studies the following conditions: Unresectable Metastatic Colorectal Cancer, Unresectable Locally Advanced Colorectal Cancer.
What interventions are being tested in trial NCT06934538?
The interventions under investigation include: STC-1010 + IS regimen + SOC therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT06934538?
This trial is sponsored by Brenus Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06934538 being conducted?
This trial has 9 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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