Injection of IP-001 into thermally ablated solid tumors.
Research type
Research Study
Full title
Intratumoral injection of IP-001 following thermal ablation in patients with advanced solid tumors. A multicenter Phase 1b/2a trial in colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma patients
IRAS ID
1005966
Contact name
Diane Beatty
Contact email
Sponsor organisation
Immunophotonics Inc.
Eudract number
2022-000176-19
ISRCTN Number
ISRCTN16103145
Research summary
Treatment in patients with advanced colorectal cancer, (CRC) non-small cell lung cancer (NSCLC) and soft tissue sarcoma (STS) represents a significant unmet need.
Local thermal ablation of tumor tissue using techniques such as radiofrequency ablation (RFA) or stereotactic radiotherapy is an established treatment option for different tumors, in particular, CRC and NSCLC.
There is strong nonclinical and early clinical evidence that combining thermal ablation with the investigational product, 1.0% IP-001 for Injection might be able to turn ‘cold’ tumors into ‘hot’ tumors, inducing a long-term systemic immune response mediated by the patient’s immunological defense system against any remaining tumor cells both at the site of the ablation treatment and those that are outside or distant from the treated area. (known as the abscopal effect)
In this study, a solid tumor will first be thermally ablated by a standard ablation modality, and then 1.0% IP-001 for Injection will be injected into the area of the ablated tumor. Patients can be treated every 6 weeks for up to 4 treatments with RFA +
1.0% IP-001 for Injection.
The 2 components of treatment play unique roles in inducing an antitumor immune response:
1) During thermal ablation, treated tumor undergoes immunogenic cell death via a well-defined heat gradient
2) Adding 1.0% IP-001 for Injection elicits a tumor-specific adaptive immune response.
As a result, it is hypothesized that Ablation + IP-001 can be deployed against a wide variety of tumor types to induce customized immune activation against a patient’s own, unique cancer.REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0508
Date of REC Opinion
26 Aug 2022
REC opinion
Further Information Favourable Opinion