The purpose of this study is to evaluate the preliminary efficacy and safety of NIS793
and other novel investigational combinations with standard of care (SOC) anti-cancer
therapy vs SOC anti-cancer therapy for the second line treatment of mCRC.
This study aims to explore whether different mechanisms of action may reverse resistance
and improve responsiveness to the currently considered SOC anti-cancer therapy in the
second line metastatic colorectal cancer (mCRC) setting.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04952753.
This is an open-label, multi-center, phase II, 2-part platform study with Safety run-in
and Expansion parts.
The platform design of this study is adaptive to allow flexibility in the introduction of
additional treatment arms with new investigational drugs in combination with SOC
anti-cancer therapy for the second line treatment of mCRC.
The study will include a control arm that will enroll participants treated with SOC
anti-cancer therapy (bevacizumab with mFOLFOX6 or FOLFIRI) for the second line treatment
of mCRC. The choice of the chemotherapy medications (mFOLFOX6 or FOLFIRI) will be
determined by the Investigator based on prior exposure to oxaliplatin or irinotecan.
Each investigational arm will include a combination of an investigational drug and the
SOC anti-cancer therapy. The first investigational arm of the study will explore the
combination of anti-transforming growth factor β (TGF-β) monoclonal antibody, NIS793 with
SOC anti-cancer therapy. The second investigational arm of the study will explore the
combination of anti-transforming growth factor β (TGF-β) monoclonal antibody, NIS793 with
Tislelizumab, which is an anti-PD1 monoclonal antibody, and SOC anti-cancer therapy.
Combination of other investigational drugs with SOC anti-cancer therapy may be added by
protocol amendments an additional investigational arms.
In each investigational arm, a Safety run-in part will be conducted before opening the
expansion part to confirm the recommended phase 2 dose (RP2D) for a combination of any
investigational drug with SOC anti-cancer therapy unless the dose has been confirmed
externally to this trial.
The decision to open the Expansion part of the study will be based on dose confirmation
of investigational drug with available safety, relevant PK and other relevant data from
Safety run-in part. Participants in the expansion part will be randomized in 1:2 ratio to
the control arm or investigational arm.
Lead OrganizationNovartis Pharmaceuticals Corporation
