On April 14, 2020 Immunophotonics reported that it has received Swissmedic approval to commence a new clinical trial entitled "Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors (Press release, Immunophotonics, APR 14, 2020, View Source [SID1234556306])." This is a multicenter phase 1B/2A trial with expansion cohorts in melanoma and soft tissue sarcoma patients. The therapeutic approach taken by this 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 in patients with laser ablation-accessible solid tumors (6 patients, "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 is a primary objective (Part 2, Cohort 2).