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
| 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. Jörger Markus |