Research & Development

Clinical Development

SCO-101 combined with FOLFIRI in metastatic colorectal cancer

CORIST, phase II

The aim of the CORIST phase II study is to investigate SCO-101 in combination with chemotherapy FOLFIRI in patients with metastatic colorectal cancer (mCRC). Patients enrolled in the CORIST trial have failed all prior standard chemotherapy and have entered a terminal stage of their disease with little hope of either a cure or of extending life further.

CORIST part 1

The first part of the CORIST phase II study, which aimed at establishing a safe dose (maximum tolerated dose) of SCO-101 when given together with FOLFIRI was successfully completed in June 2021. SCO-101 was administered once daily on day 1 to day 6 and FOLFIRI was administered on day 5 to 7.

CORIST part 2

The second part of the CORIST phase II study only included patients with RAS wild-type tumors, based on findings in CORIST part 1. Part 2 of the CORIST study focused on safety, tolerability, and efficacy parameters, for SCO-101 on a schedule combining SCO-101 and FOLFIRI over 7 days.

Topline data from CORIST part 2 were presented on 30 September 2022 (please see Press releases).

CORIST part 3

In August 2022, Scandion Oncology received approvals for the next parts of the CORIST trial. CORIST part 3 and potentially part 4 represent an expansion of CORIST phase II, in order to best exploit SCO-101’s potential in mCRC.

The trial was expanded by adding new schedule for combining SCO-101 and chemotherapy (FOLFIRI) over 6 and 4 days, which will be evaluated in patients with both RAS wild-type and RAS mutated tumors.

Patient recruitment in part 3 commenced in Q3, 2022, and topline results from CORIST part 3 are expected within second half of 2023. If preliminary safety and activity results are supportive, it is planned to conduct CORIST part 4 with an expanded number of patients to confirm the activity of this drug combination.

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.

Topline results from PANTAX were presented on 31 March 2023 (please see Press releases).

Final read-out from the PANTAX phase Ib study is expected in the first half of 2024.