Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors.
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
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.
Patients with laser ablation-accessible solid tumors are treated by thermal ablation followed
immediately by an intratumoral injection of IP-001 (1 % N-dihydro-galacto-chitosan,
Immunophotonics Inc.) for injection). IP-001 is intended to trigger a tumor-specific systemic
immune response when exposed to tumor antigens liberated by thermal ablation. 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. This may
result in shrinkage of the treated tumor, as well as, long-term response mediated by the
patient's immunological defense system against any remaining tumor cells (residual primary
and metastatic tumor cells) including tumor cells outside or distant from the treated area
(also known as abscopal effect).
This trial will provide information on the safety and tolerability of thermal ablation
followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) in patients with
laser ablation-accessible solid tumors ('all comers', Part 1 - safety run in). Further
information on safety and tolerability, as well as preliminary antitumor activity, will be
evaluated in patients with soft tissue sarcoma (Part 2, Cohort1), whereas in melanoma
patients, anti-tumor activity will be defined as a primary objective (Part 2, Cohort 2).
The trial treatment consists of an Ablation + IP-001 in 4-week intervals for up to 6
scheduled treatments. Thermal ablation will be performed according to the instruction of the
medical device, and IP-001 will be administered in different dose levels according to the
trial design. All patients will be followed until progression of disease or until the start
of a subsequent treatment.