Noxxon Pharma has commenced a Phase I/II clinical trial to assess its CXCL12 inhibitor, NOX-A12, in combination with external-beam radiotherapy to treat newly diagnosed brain cancer.
NOX-A12 is an investigational drug being developed as a combination therapy for the treatment of various cancers. It is intended to act on the tumour microenvironment and boost the effectiveness of anti-cancer therapies.
Previously, NOX-A12 has been studied in combination with Merck’s Keytruda in patients with metastatic colorectal and pancreatic cancer, chronic lymphocytic leukaemia and multiple myeloma.
The new Phase I/II study will evaluate the safety and efficacy of the combination. It will also determine a recommended Phase II dose (RP2D).
Investigators will also non-invasively examine the tumour vascularisation changes to confirm the mechanism of action predicted for the combination.
The trial is being conducted at three hospitals in Germany. It will involve patients who would not benefit from the current standard of care of chemotherapy and whose tumours cannot be completely resected by surgery.
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The first patient in the trial has been enrolled and treated. Participants will receive three escalating doses of NOX-A12 in combination with standard radiotherapy as a first-line treatment.
In addition to safety and tolerability of the combination, the trial will monitor its activity via tumour vascularisation tracked using MRI scans, progression-free survival, overall survival and response rates.
Noxxon Pharma chief medical officer Dr Jarl Ulf Jungnelius said: “Based on promising preclinical data in rat and mouse models, we are excited to evaluate NOX-A12 in this indication.
“It is a unique and promising approach with the potential to effectively treat brain cancer patients for whom there are currently no optimal therapies.”
The company expects to report findings from the Phase I/II trial’s first cohort mid next year.