Clinical Trials

Phase II


CORIST
CORIST, Scandion Oncology’s first clinical study with SCO-101 is a Phase II study. In this study, patients with chemotherapy (FOLFIRI) resistant metastatic colorectal cancer (mCRC) 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 first part of the CORIST Phase II study, safety and tolerability were investigated combining SCO-101 with chemotherapy. The goal was to establish a safe dose (maximum tolerated dose – MTD) of SCO-101 when given together with FOLFIRI.

In June 2021, Scandion Oncology reported that a well tolerated dose of SCO-101 in combination with FOLFIRI had been established (MTD), and that the recommended dose for part 2 of the study had been identified. Furthermore, the oncogene RAS was identified as a predictive biomarker, which will be used to optimize the inclusion of patients in part 2 of the study.

In part 2 of CORIST Phase II (proof-of-concept study), mCRC patients with RAS wild-type tumors are treated with SCO-101 and FOLFIRI according to the recommended dose 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. Part 2 of the CORIST study is planned to include 25 patients.

Data read-out from part 2 of the CORIST study is planned for Q2-Q3, 2022.

 

Phase Ib


PANTAX
PANTAX is Scandion Oncology’s second clinical study with SCO-101. In this study, patients with unresectable or metastatic pancreatic cancer receive SCO-101 treatment in combination with nab-paclitaxel and gemcitabine which is standard first- or second-line chemotherapy.

The PANTAX study consists of two parts. In the first part (Phase Ib), the Company aims to establish a safe dose (maximum tolerated dose) of SCO-101 in combination with nab-paclitaxel and gemcitabine.

In the second part (Phase II), patients will be randomized to receive nab-paclitaxel and gemcitabine in combination with SCO-101 (40 patients) or nab-paclitaxel and gemcitabine alone (20 patients).

Data read-out from the PANTAX Phase Ib study is planned for Q2-Q3, 2022.

 

Phase I


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.