CORIST, Scandion Oncology’s first clinical study with SCO-101 is a Phase II study. In this study, patients with chemotherapy (FOLFIRI) resistant and metastatic colorectal cancer receive SCO-101 treatment together with the standard chemotherapy drug combination FOLFIRI. All patients enrolled in the trial have demonstrated acquired FOLFIRI resistance.
In the CORIST colorectal cancer study part 1, safety and tolerability are investigated combining SCO-101 with chemotherapy. The goal is to establish a safe dose (Maximum Tolerable Dose) of SCO-101 when given together with FOLFIRI.
In part 2 of CORIST, 25 patients will be treated with SCO-101 and FOLFIRI according to the recommended dose for Phase II identified in part 1 of the CORIST study. Efficacy as determined by changes in the size of the patient’s tumor tissue will be the primary endpoint.
Primary efficacy endpoint: Objective response rate
Scandion Oncology’s second clinical study with SCO-101 is a Phase Ib study named PANTAX. In this study patients with inoperable or metastatic pancreatic cancer receive SCO-101 treatment in combination with standard first line chemotherapy (Nab-paclitaxel and gemcitabine).
The PANTAX study consists of two parts: part 1 (Phase Ib), where the Company defines the dose of SCO-101 that can be given together with standard first line chemotherapy (Nab-paclitaxel plus gemcitabine).
In part 2 (Phase II), patients will be randomized to receive either standard chemotherapy (Nab-paclitaxel plus gemcitabine) (20 patients) or the same chemotherapy plus SCO-101 (40 patients). Since this study is randomized, Scandion Oncology can compare progression-free survival and overall survival between the two treatment groups. When the first 60 patients have been treated, an interim analysis will be performed. Based on these results it will be decided if more patients should be included in the study.
Endpoints: Safety, PFS, OS and clinical benefit rate
Four different Phase I studies, with a total of 92 healthy volunteers have been conducted.
SCO-101 was found to have a favourable safety profile.