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 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 max

Trial Details

NCT ID

NCT06934538

Phase

PHASE1 / PHASE2

Sponsor

Brenus Pharma

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

STC-1010 + IS regimen + SOC therapy

Locations (sample)

Baltimore, Maryland, United States|39.29038,-76.61219
Brussels, Belgium|50.85045,4.34878
Bordeaux, France|44.84124,-0.58046
Dijon, France|47.31344,5.01391
Lyon, France|45.74906,4.84789

Key Eligibility Criteria

Male or female aged 18-75 years
Histologically confirmed diagnosis of unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) (R0) adenocarcinoma of …
Adjuvant fluoropyrimidine monotherapy or oxaliplatin-based chemotherapy allowed if more than 6 months have elapsed between the end of adjuvant trea…
Determination of KRAS and BRAF mutation status

For full eligibility, visit ClinicalTrials.gov.

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