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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Brenus Pharma
Study ID
NCT06934538
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Unresectable Locally Advanced Colorectal Cancer
  • Unresectable Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • STC-1010 + IS regimen + SOC therapy — BIOLOGICAL
    STC-1010 administered with immunostimulants (IS) in low-dose (cyclophosphamide and GM-CSF) and standard of care (SOC) therapy (mFOLFOX6 with or without bevacizumab)

Study Details

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.

Key Dates

Start date
Jun 17, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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
  • 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
  • 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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns HopkinsBaltimoreMaryland21287
Eric Christenson, MD
[email protected]
410-955-8964

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By research site
Johns Hopkins· Baltimore, MD

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