SCO-101 combined with FOLFIRI in metastatic colorectal cancer
CORIST, Phase II
In the CORIST Phase II 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.
The goal of the first part of the CORIST Phase II study was to establish the 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 mutational status of the oncogene RAS was identified as a predictive biomarker, where patients with RAS wild-type tumors tolerated the treatment better and stayed longer on treatment compared to patients with RAS mutated tumors. This finding has been implemented in the second part of the CORIST study, which only enrols mCRC patients with RAS wild-type tumors.
In the ongoing 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 study. Part 2 is planned to include 25 patients and will continue the focus on safety, tolerability, and efficacy parameters, to establish proof-of-concept for SCO-101 in combination with FOLFIRI.
Data read-out from part 2 of the CORIST Phase II study is planned for Q2-Q3, 2022, most likely Q3 2022.
SCO-101 combined with nab-paclitaxel and gemcitabine in pancreatic cancer
PANTAX, Phase Ib
In the PANTAX 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 aim of the ongoing Phase Ib study is to establish a safe dose (maximum tolerated dose) of SCO-101 in combination with nab-paclitaxel and gemcitabine.
Data read-out from the PANTAX Phase Ib study is planned for Q2-Q3, 2022, most likely Q3 2022.