NCT03993678

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

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: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 (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).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	IP-001	Dose and route: Immediately (within 15 - 30 min) after thermal ablation, IP-001 will be injected in and around the ablated lesion. The amount of IP-001 injected depends on the dose level.
DEVICE	Thermal Ablation	The medical device includes a laser unit. The system continuously measures the temperature of the tissue, guiding the user to perform precise and safe treatments. Treatment time: 30 min

Timeline

• Start date: 2020-10-12
• Primary completion: 2025-07-15
• Completion: 2025-07-19
• First posted: 2019-06-21
• Last updated: 2025-12-30

Locations

3 sites across 1 country: Switzerland