Brenus Pharma, a French biotech company developing the innovative “Stimulated-Tumor-Cell” (STC) discovery platform, has unveiled the study design for its first-in-human trial, “BreAK-CRC,” featuring their lead candidate, STC-1010. This presentation took place during the Trials in Progress poster session at the ASCO annual meeting in Chicago, held from May 31st to June 4th, 2024.
About BreAK-CRC Study:
The BreAK-CRC study, backed by a robust preclinical package of in vivo, in ovo, and ex vivo data, will be conducted across nine early-phase oncology centers in Europe and the US. These centers are staffed by expert investigators specializing in immunotherapy.
Dr. François Ghiringhelli (M.D, PhD), Director of the early clinical unit CLIPP2 and BreAK-CRC study coordinator at Centre Georges-François Leclerc, University of Burgundy, Dijon, France, stated, “Cancer vaccines continue to show promising clinical results in solid tumors. STC-1010, a new immunotherapeutic approach based on the cancer vaccine mechanism, holds significant promise for colorectal cancer patients. The BreAK-CRC study is highly anticipated, particularly for the pMMR/MSS population, which represents 95% of CRC patients and urgently needs effective treatments to convert ‘cold’ tumors into ‘hot’ tumors, potentially improving patient outcomes.”
Study Protocol and Approval:
The BreAK-CRC trial protocol has been reviewed in a pre-submission meeting with the French National Health Authority. The Clinical Trial Application (CTA) submission through the European Union’s clinical trial information system is currently in progress.
Trial Phases:
The Phase I/IIA clinical trial aims to evaluate the safety and efficacy of STC-1010 in patients with unresectable advanced or metastatic colorectal cancer, which is the second leading cause of cancer mortality worldwide.
- Phase I: This phase will assess the tolerability of two dose levels of STC-1010, in combination with low-dose immunostimulants and standard-of-care chemotherapy (SoC).
- Phase IIA: This phase will enroll patients to further evaluate the treatment’s efficacy, with a particular focus on the 12-month non-progression rate.
Exploratory Analysis:
In addition to the primary objectives, exploratory analyses will evaluate the immune response and ctDNA dynamics in the treated patients.