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

Advanced Solid Tumors Clinical Trial

Official title: 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.

Status Not yet recruiting

Clinical Trial 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 injection of IP-001. IP-001 is intended to trigger a tumor-specific systemic immune response when exposed to thermally liberated tumor antigens. 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.

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 and as well preliminary antitumor activity will be evaluated in patients with soft tissue sarcoma (Part 2, Cohort1) and addition, in melanoma patients the 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 six scheduled treatments. Thermal ablation will be performed according to the instruction of the medical device and IMP IP-001 will be administered in different dose levels according to the trial design. A follow up of all patients until progression of disease or until start of a subsequent treatment is part of the trial.

Clinical Trial Description

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 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.

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 (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 acitivity 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). ;

Related Conditions & MeSH terms

• Advanced Solid Tumors

• NCT number: NCT03972436
• Study type: Interventional
• Source: Swiss Group for Clinical Cancer Research
• Contact: Katrin Eckhardt, PhD
• Phone: +41 31 389 91 91
• Email: trials@sakk.ch
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: August 1, 2019
• Completion date: December 31, 2023