For the phase 1 part (part A) is a dose-escalation study of IV visugromab (CTL-002, a monoclonal antibody that neutralizes GDF-15) as monotherapy and in combination with an approved checkpoint inhibitor (CPI) in patients with advanced solid tumors. For the phase 2 parts (part B) are cohort expansions with Visugromab (CTL-002) in combination with a defined CPI at a fixed dose in seven different solid tumor indications.
Aim of the study
You are being invited to participate in this clinical trial because you have been diagnosed with a recurrent or advanced stage solid tumor and unfortunately your disease has returned or has not responded to available treatment. You may also have previously received cancer therapy and anti-PD-1/PD-L1 treatment. Anti-PD-1/PD-L1 is a "checkpoint inhibitor" that works by blocking proteins known as checkpoints, which are found in some types of immune cells. The novel drug tested in this study (CTL-002) is intended to make anti-PD1/PD-L1 therapy effective again in patients for whom it is not or no longer effective.
Who can take part?
Patients with advanced solid tumors
Procedure
Part A of the study has now been successfully completed. Several patients in this phase of the study experienced tumor shrinkage as a result of the study treatment. You will participate in Part B of the study and you will receive CTL-002 in combination with the approved and marketed anti-PD-1 antibody nivolumab. Your participation in Part B of this clinical trial is expected to last 18 months (including the follow-up period), but may be longer or significantly shorter depending on treatment duration and tolerability.
Compensation
None
Original study name
A two-part, open-label Phase 1/2 FIH clinical trial of intravenous (IV) administration of CTL-002 as monotherapy and/or in combination with an anti-PD-1 checkpoint inhibitor in patients with advanced, recurrent/refractory solid tumors
BASEC number
2020-02308
Financial support from
CatalYm Ltd.