Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors.

Summary

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Despite constant progress in the treatment of patients with advanced 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 che...

Despite constant progress in the treatment of patients with advanced 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 treatment 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 (1 % N-dihydro-galacto-chitosan, Immunophotonics Inc.) for injection) 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). The primary objective of Part 1 is to determine 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'). The primary objective of Part 2 - Cohort 1 (soft tissue sarcoma, STS) is to further determine the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) in the dose established in Part 1 of the trial. The primary objective of Part 2 - Cohort 2 (melanoma) of the trial is to define anti-tumor activity of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) utilizing the dose established in Part 1 of the trial. The secondary objective of the trial is to further determine the safety and tolerability of IP-001 (Part 2, Cohort 1 and 2) to assess the preliminary anti-tumor activity in STS patients (Part 2, Cohort 1) to observe further signs of clinical preliminary anti-tumor activity in patients with melanoma (Part 2, Cohort 2).

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