Kantonsspital St.Gallen

Trial: SAKK 66/17 Intratumoral injection of IP-001 following thermal ablation in patients with advanced solid tumors. A multicenter phase Ib/IIa trial with expansion cohorts in melanoma and soft tissue sarcoma patients

Markus Joerger

abstract Background and Rationale
Despite constant progress in the treatment of patients with ad-
vanced solid tumors failing standard systemic treatment, there is
still a high unmet medical need to develop new active anticancer
drugs or therapies. Although patients with advanced melanoma
have benefitted substantially from the new checkpoint inhibitors,
monoclonal antibodies, etc., those patients progressing after such treatment are still in high need of additional treatment options. In
the field of advanced sarcoma, little to no progress has been
made in the last years, and chemotherapy is still standard treat-
ment for these patients. The therapeutic approach taken by trial
SAKK 66/17 is different from those already used in clinical
practice and possibly offers patients a therapeutic benefit after
failure of standard chemotherapy and immunotherapy. There is
strong preclinical and early clinical evidence that combining
thermal ablation with IP-001 might be able to turn ‘cold’ tumors
into ‘hot’ tumors, inducing a systemic immune response and
resulting in shrinkage of the treated tumor including long-term
response mediated by the patient’s immunological defense
system against any remaining tumor cells (residual primary and
metastatic tumor cells) even those that are outside or distant
from the treated area.
type of project clinical studies
status ongoing - recruiting phase
start of project 2020
end of project 2024
study design Phase Ib/IIa
responsible person Prof. Dr. med. J├Ârger Markus